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This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00548262
Collaborator
(none)
54
Enrollment
13
Locations
1
Arm
20
Duration (Months)
4.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole, For Treatment Of Documented Candidemia/Invasive Candidiasis In Hospitalized Patients
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: Anidulafungin
All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin.
Other Names:
  • Eraxis

    • Drug: Voriconazole
    Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg BID (or 100 mg BID if <40 kg body weight) therapy on Day 5 and thereafter, starting with a loading dose of 400 mg BID (or 200 mg BID if <40 kg body weight).
    Other Names:
  • Vfend

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment [End of Treatment (EOT) (up to Day 42)]

      Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).

    Secondary Outcome Measures

    1. Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) [End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up]

      Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).

    2. Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT [Baseline, EIVT (up to Day 42)]

      Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.

    3. Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT [Baseline, EOT (up to Day 42)]

      Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.

    4. Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up [Baseline, Week 2 Follow-up]

      Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.

    5. Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT [Baseline, EOT (up to Day 42)]

      Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

    6. Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT [EIVT (up to Day 42)]

      Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

    7. Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up [Baseline, Week 2 Follow-up (F/U)]

      Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

    8. Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score [EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up]

      Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score <20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.

    9. Number of Participants Per Survival Status (Alive or Dead) on Day 30 [Day 30]

    10. Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis [Baseline to Week 6 Follow-up]

      Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded "disease under study" as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone.

    11. Time to Negative Blood, Specimen, or Tissue Culture [Baseline to Week 2 Follow-up]

      Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).

    12. Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment [Baseline to Day 42]

      Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.

    13. Length of Hospital Stay [Baseline to Week 6 Follow-up]

      Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.

    14. Length of Stay in Intensive Care Unit (ICU) [Baseline up to Week 6 Follow-up]

      Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.

    15. Change From Baseline in Vital Signs: Supine Blood Pressure [Baseline to Week 2 Follow-up]

      Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).

    16. Change From Baseline in Vital Signs: Supine Heart Rate [Baseline to Week 2 Follow-up]

      Supine heart rate measured as beats per minute (bpm).

    17. Change From Baseline in Vital Signs: Weight [Baseline to Week 2 Follow-up]

      Weight measured as kilograms (kg).

    18. Change From Baseline in Vital Signs: Temperature [Baseline to Week 2 Follow-up]

      Temperature measured as degrees of Celsius (C).

    19. Change From Baseline in Vital Signs: Respiration Rate [Baseline to Week 2 Follow-up]

      Respiration rate measured as respirations per minute (resp/min).

    20. Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) [Baseline to Week 2 Follow-up]

      Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).

    21. Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) [Baseline to Week 2 Follow-up]

      Chemistry laboratory test data measured as international units per (IU/L).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female patient 18 years of age and older.

    • If female, must be post-menopausal, surgically sterile or using adequate contraception,not lactating, and have a negative urine or blood pregnancy test at screening, prior to administration of study medication.

    • Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours to study entry ((informed consent provided).

    • Presence of one or more of the following signs and symptoms of acute fungal infection within the prior 48 hours to initiation of study treatment:

    • Fever defined as oral temperature greater than or equal to 38 degrees C (100.4 degrees F); rectal or core temperature greater than or equal to 38.6 degrees C (101.4 degrees F), or axillary temperature greater than or equal to 37.5 degrees Celsius (99.5 degrees F). Hypothermia defined as rectal or core temperature less than 36.0 degrees C (96.8 degrees F).

    • Hypotension (systolic blood pressure [SBP] less than 100 mmHg, or SBP decrease greater than or equal to 30 mm Hg from baseline.

    • Localized signs and symptoms of inflammation (swelling, heat, erythema or purulence at a site infected with Candida spp.).

    • Patient is classified in one of following categories based on previous antifungal treatment: received less than 48 hours of previous systemic antifungal therapy and no more than a single dose of echinocandin therapy prior to study entry; intolerant to infusion related toxicities of amphotericin B preparations despite appropriate supportive measures or serum creatinine increased by >1.5 mg/dl while receiving conventional or lipid amphotericin B therapy; or lack of clinical response and/or persistent positive blood culture after at least seven days of systemic antifungal treatment with a polyene or fluconazole at an adequate dose.

    • APACHE II 9 score < 25 at study entry.

    • Patients willing and able to give informed consent, or have a legally authorized representative willing to give informed consent on the patients behalf.

    • Expected survival (in the opinion of the investigator) greater than 4 days.

    Exclusion Criteria:

    • Hypersensitivity to anidulafungin, other echinocandins or azoles.

    • Participation presently or within the last 30 days in a trial with other investigational drug(s). Patients on antiretroviral or chemotherapy regimens which include an investigational drug may participate provided that there has been no change in their therapy during the past 4 weeks and no change in treatment is anticipated during study participation.

    • Chronic refractory neutropenia defined as absolute neutrophils count <500 cells/mm3 for 28 days prior to the baseline visit.

    • Confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.

    • Poor venous access that would preclude IV drug delivery or multiple blood draws.

    • Prosthetic devices at a suspected site of infection unless the device is removed within 24 hours of study entry.

    • Fungal endophthalmitis confirmed by fundoscopy.

    • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration that may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the Patient inappropriate for entry into this trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Brasilia DF Brazil 70710-905
    2 Pfizer Investigational Site Curitiba PR Brazil 80060-900
    3 Pfizer Investigational Site Rio de Janeiro RJ Brazil 21941-913
    4 Pfizer Investigational Site Porto Alegre RS Brazil 90020-090
    5 Pfizer Investigational Site Porto Alegre RS Brazil 90110-270
    6 Pfizer Investigational Site Sao Jose do Rio Preto SP Brazil 15090-000
    7 Pfizer Investigational Site Independencia Santiago, RM Chile 8380456
    8 Pfizer Investigational Site Bogota DC Cundinamarca Colombia 0000
    9 Pfizer Investigational Site Cali Valle Del Cauca Colombia 0000
    10 Pfizer Investigational Site Leon Guanajuato Mexico 37320
    11 Pfizer Investigational Site Guadalajara Jalisco Mexico 44280
    12 Pfizer Investigational Site San Luis Potosi Mexico 78240
    13 Pfizer Investigational Site Panama Panama

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00548262
    Other Study ID Numbers:
    • A8851015
    First Posted:
    Oct 23, 2007
    Last Update Posted:
    Jan 17, 2011
    Last Verified:
    Dec 1, 2010
    Keywords provided by , ,
    Open-label
    non-comparative study to evaluate short course of IV anidulafungin
    followed by oral voriconazole
    for tx of candidemia/invasive candidiasis.
    Additional relevant MeSH terms:
    Candidiasis
    Candidemia
    Candidiasis, Invasive
    Voriconazole
    Anidulafungin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail The planned sample size for this study was 210 subjects; however, due to slow enrollment, only 54 subjects were screened and randomized.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Period Title: Overall Study
    STARTED 54
    COMPLETED 22
    NOT COMPLETED 32

    Baseline Characteristics

    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Overall Participants 54
    Age, Customized (participants) [Number]
    Between 18 and 44 years
    18
    33.3%
    Between 45 and 64 years
    18
    33.3%
    ≥ 65 years
    18
    33.3%
    Sex: Female, Male (Count of Participants)
    Female
    32
    59.3%
    Male
    22
    40.7%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment
    Description Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).
    Time Frame End of Treatment (EOT) (up to Day 42)

    Outcome Measure Data

    Analysis Population Description
    Modified Intent-to-Treat population (MITT): all Intent-to-Treat (ITT) participants (took at least 1 dose of study treatment) and with a positive baseline culture for a Candida spp within 96 hours before entry into the study. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    Success
    26
    48.1%
    Failure
    18
    33.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Success at EOT
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 59.1
    Confidence Interval (2-Sided) 95%
    44.6 to 73.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    2. Secondary Outcome
    Title Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)
    Description Clinical Success (cure=resolution of Candida signs and symptoms [s/s] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or Failure (persistence=positive culture for at least 1 baseline Candida spp or presumed persistence=f/u culture n/a and clinical outcome defined as failure).
    Time Frame End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    MITT. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for Failure.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    EIVT Success
    26
    48.1%
    EIVT Failure
    18
    33.3%
    Week 2 Follow-up Success
    21
    38.9%
    Week 2 Follow-up Failure
    23
    42.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments EIVT Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 59.1
    Confidence Interval (2-Sided) 95%
    44.6 to 73.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Week 2 Follow-up Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 47.7
    Confidence Interval (2-Sided) 95%
    33.0 to 62.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    3. Secondary Outcome
    Title Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT
    Description Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.
    Time Frame Baseline, EIVT (up to Day 42)

    Outcome Measure Data

    Analysis Population Description
    MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    Candida albicans: Success
    11
    20.4%
    Candida albicans: Failure
    10
    18.5%
    Candida famata: Success
    1
    1.9%
    Candida famata: Failure
    1
    1.9%
    Candida glabrata: Success
    2
    3.7%
    Candida glabrata: Failure
    1
    1.9%
    Candida guilliermondii: Success
    1
    1.9%
    Candida guilliermondii: Failure
    0
    0%
    Candida krusei: Success
    2
    3.7%
    Candida krusei: Failure
    1
    1.9%
    Candida parapsilosis: Success
    1
    1.9%
    Candida parapsilosis: Failure
    5
    9.3%
    Candida pelliculosa: Success
    1
    1.9%
    Candida pelliculosa: Failure
    0
    0%
    Candida tropicalis: Success
    8
    14.8%
    Candida tropicalis: Failure
    2
    3.7%
    Unidentifiable: Success
    4
    7.4%
    Unidentifiable: Failure
    3
    5.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida albicans: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 52.4
    Confidence Interval (2-Sided) 95%
    31.0 to 73.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida famata: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 50.0
    Confidence Interval (2-Sided) 95%
    0.0 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida glabrata: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 66.7
    Confidence Interval (2-Sided) 95%
    13.3 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida krusei: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 66.7
    Confidence Interval (2-Sided) 95%
    13.3 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida parapsilosis: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 16.7
    Confidence Interval (2-Sided) 95%
    0.0 to 46.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida tropicalis: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 80.0
    Confidence Interval (2-Sided) 95%
    55.2 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Unidentifiable: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 57.1
    Confidence Interval (2-Sided) 95%
    20.5 to 93.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    4. Secondary Outcome
    Title Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT
    Description Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.
    Time Frame Baseline, EOT (up to Day 42)

    Outcome Measure Data

    Analysis Population Description
    MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    Candida albicans: Success
    11
    20.4%
    Candida albicans: Failure
    10
    18.5%
    Candida famata: Success
    0
    0%
    Candida famata: Failure
    2
    3.7%
    Candida glabrata: Success
    2
    3.7%
    Candida glabrata: Failure
    1
    1.9%
    Candida guilliermondii: Success
    1
    1.9%
    Candida guilliermondii: Failure
    0
    0%
    Candida krusei: Success
    2
    3.7%
    Candida krusei: Failure
    1
    1.9%
    Candida parapsilosis: Success
    1
    1.9%
    Candida parapsilosis: Failure
    5
    9.3%
    Candida pelliculosa: Success
    1
    1.9%
    Candida pelliculosa: Failure
    0
    0%
    Candida tropicalis: Success
    8
    14.8%
    Candida tropicalis: Failure
    2
    3.7%
    Unidentifiable: Success
    4
    7.4%
    Unidentifiable: Failure
    3
    5.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida albicans: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 52.4
    Confidence Interval (2-Sided) 95%
    31.0 to 73.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida glabrata: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 66.7
    Confidence Interval (2-Sided) 95%
    13.3 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida krusei: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 66.7
    Confidence Interval (2-Sided) 95%
    13.3 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida parapsilosis: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 16.7
    Confidence Interval (2-Sided) 95%
    0.0 to 46.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida tropicalis: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 80.0
    Confidence Interval (2-Sided) 95%
    55.2 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Unidentifiable: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 57.1
    Confidence Interval (2-Sided) 95%
    20.5 to 93.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    5. Secondary Outcome
    Title Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up
    Description Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.
    Time Frame Baseline, Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    MITT. Missing or indeterminate set to Failure; CI was not calculated for status of Failure.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    Candida albicans: Success
    10
    18.5%
    Candida albicans: Failure
    11
    20.4%
    Candida famata: Success
    0
    0%
    Candida famata: Failure
    2
    3.7%
    Candida glabrata: Success
    3
    5.6%
    Candida glabrata: Failure
    0
    0%
    Candida guilliermondii: Success
    1
    1.9%
    Candida guilliermondii: Failure
    0
    0%
    Candida krusei: Success
    2
    3.7%
    Candida krusei: Failure
    1
    1.9%
    Candida parapsilosis: Success
    0
    0%
    Candida parapsilosis: Failure
    6
    11.1%
    Candida pelliculosa: Success
    1
    1.9%
    Candida pelliculosa: Failure
    0
    0%
    Candida tropicalis: Success
    7
    13%
    Candida tropicalis: Failure
    3
    5.6%
    Unidentifiable: Success
    2
    3.7%
    Unidentifiable: Failure
    5
    9.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida albicans: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 47.6
    Confidence Interval (2-Sided) 95%
    26.3 to 69.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida krusei: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 66.7
    Confidence Interval (2-Sided) 95%
    13.3 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Candida tropicalis: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 70.0
    Confidence Interval (2-Sided) 95%
    41.6 to 98.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Unidentifiable: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 28.6
    Confidence Interval (2-Sided) 95%
    0.0 to 62.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    6. Secondary Outcome
    Title Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT
    Description Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
    Time Frame Baseline, EOT (up to Day 42)

    Outcome Measure Data

    Analysis Population Description
    MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly (>65 years of age); not summarized.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    ICU stay ≥ 4 days (Yes): Success
    18
    33.3%
    ICU stay ≥ 4 days (Yes): Failure
    14
    25.9%
    ICU stay ≥ 4 days (No): Success
    8
    14.8%
    ICU stay ≥ 4 days (No): Failure
    4
    7.4%
    Mechanical ventilation (Yes): Success
    18
    33.3%
    Mechanical ventilation (Yes): Failure
    15
    27.8%
    Mechanical ventilation (No): Success
    8
    14.8%
    Mechanical ventilation (No): Failure
    3
    5.6%
    Antibiotics (Yes): Success
    22
    40.7%
    Antibiotics (Yes): Failure
    17
    31.5%
    Antibiotics (No): Success
    4
    7.4%
    Antibiotics (No): Failure
    1
    1.9%
    CV Catheter (Yes): Success
    21
    38.9%
    CV Catheter (Yes): Failure
    17
    31.5%
    CV Catheter (No): Success
    5
    9.3%
    CV Catheter (No): Failure
    1
    1.9%
    TPN (Yes): Success
    5
    9.3%
    TPN (Yes): Failure
    8
    14.8%
    TPN (No): Success
    21
    38.9%
    TPN (No): Failure
    10
    18.5%
    Dialysis (Yes): Success
    3
    5.6%
    Dialysis (Yes): Failure
    4
    7.4%
    Dialysis (No): Success
    23
    42.6%
    Dialysis (No): Failure
    14
    25.9%
    Abdominal surgery (Yes): Success
    11
    20.4%
    Abdominal surgery (Yes): Failure
    8
    14.8%
    Abdominal surgery (No): Success
    15
    27.8%
    Abdominal surgery (No): Failure
    10
    18.5%
    Solid organ transplant (No): Success
    26
    48.1%
    Solid organ transplant (No): Failure
    18
    33.3%
    Renal insufficiency (Yes): Success
    3
    5.6%
    Renal insufficiency (Yes): Failure
    4
    7.4%
    Renal insufficiency (No): Success
    23
    42.6%
    Renal insufficiency (No): Failure
    14
    25.9%
    Chemotherapy (Yes): Success
    1
    1.9%
    Chemotherapy (Yes): Failure
    0
    0%
    Chemotherapy (No): Success
    25
    46.3%
    Chemotherapy (No): Failure
    18
    33.3%
    Pancreatitis (Yes): Success
    1
    1.9%
    Pancreatitis (Yes): Failure
    4
    7.4%
    Pancreatitis (No): Success
    25
    46.3%
    Pancreatitis (No): Failure
    14
    25.9%
    Systemic steroids/immunos (Yes): Success
    6
    11.1%
    Systemic steroids/immunos (Yes): Failure
    6
    11.1%
    Systemic steroids/immunos (No): Success
    20
    37%
    Systemic steroids/immunos (No): Failure
    12
    22.2%
    Neutropenic: Success
    2
    3.7%
    Neutropenic: Failure
    1
    1.9%
    Non-neutropenic: Success
    18
    33.3%
    Non-neutropenic: Failure
    11
    20.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments ICU stay ≥ 4 days (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 56.3
    Confidence Interval (2-Sided) 95%
    39.1 to 73.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments ICU stay ≥ 4 days (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 66.7
    Confidence Interval (2-Sided) 95%
    40.0 to 93.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Mechanical ventilation (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 54.5
    Confidence Interval (2-Sided) 95%
    37.6 to 71.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Mechanical ventilation (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 72.7
    Confidence Interval (2-Sided) 95%
    46.4 to 99.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Antibiotics (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 56.4
    Confidence Interval (2-Sided) 95%
    40.8 to 72.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Antibiotics (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 80.0
    Confidence Interval (2-Sided) 95%
    44.9 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments CV Catheter (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 55.3
    Confidence Interval (2-Sided) 95%
    39.5 to 71.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments CV Catheter (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 83.3
    Confidence Interval (2-Sided) 95%
    53.5 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments TPN (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 38.5
    Confidence Interval (2-Sided) 95%
    12.0 to 64.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments TPN (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 67.7
    Confidence Interval (2-Sided) 95%
    51.3 to 84.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Dialysis (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 42.9
    Confidence Interval (2-Sided) 95%
    6.2 to 79.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Dialysis (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 62.2
    Confidence Interval (2-Sided) 95%
    46.5 to 77.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Abdominal surgery (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 57.9
    Confidence Interval (2-Sided) 95%
    35.7 to 80.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Abdominal surgery (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 60.0
    Confidence Interval (2-Sided) 95%
    40.8 to 79.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Solid organ transplant (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 59.1
    Confidence Interval (2-Sided) 95%
    44.6 to 73.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Renal insufficiency (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 42.9
    Confidence Interval (2-Sided) 95%
    6.2 to 79.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Renal insufficiency (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 62.2
    Confidence Interval (2-Sided) 95%
    46.5 to 77.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Chemotherapy (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 58.1
    Confidence Interval (2-Sided) 95%
    43.4 to 72.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Pancreatitis (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 20.0
    Confidence Interval (2-Sided) 95%
    0.0 to 55.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Pancreatitis (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 64.1
    Confidence Interval (2-Sided) 95%
    49.0 to 79.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Systemic steroids/immunos (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 50.0
    Confidence Interval (2-Sided) 95%
    21.7 to 78.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Systemic steroids/immunos (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 62.5
    Confidence Interval (2-Sided) 95%
    45.7 to 79.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Neutropenic: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 66.7
    Confidence Interval (2-Sided) 95%
    13.3 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Non-neutropenic: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 62.1
    Confidence Interval (2-Sided) 95%
    44.4 to 79.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    7. Secondary Outcome
    Title Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT
    Description Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
    Time Frame EIVT (up to Day 42)

    Outcome Measure Data

    Analysis Population Description
    MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly >65 years of age; not summarized.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    ICU stay ≥ 4 days (Yes): Success
    18
    33.3%
    ICU stay ≥ 4 days (Yes): Failure
    14
    25.9%
    ICU stay ≥ 4 days (No): Success
    8
    14.8%
    ICU stay ≥ 4 days (No): Failure
    4
    7.4%
    Mechanical ventilation (Yes): Success
    18
    33.3%
    Mechanical ventilation (Yes): Failure
    15
    27.8%
    Mechanical ventilation (No): Success
    8
    14.8%
    Mechanical ventilation (No): Failure
    3
    5.6%
    Antibiotics (Yes): Success
    22
    40.7%
    Antibiotics (Yes): Failure
    17
    31.5%
    Antibiotics (No): Success
    4
    7.4%
    Antibiotics (No): Failure
    1
    1.9%
    CV Catheter (Yes): Success
    21
    38.9%
    CV Catheter (Yes): Failure
    17
    31.5%
    CV Catheter (No): Success
    5
    9.3%
    CV Catheter (No): Failure
    1
    1.9%
    TPN (Yes): Success
    6
    11.1%
    TPN (Yes): Failure
    7
    13%
    TPN (No): Success
    20
    37%
    TPN (No): Failure
    11
    20.4%
    Dialysis (Yes): Success
    3
    5.6%
    Dialysis (Yes): Failure
    4
    7.4%
    Dialysis (No): Success
    23
    42.6%
    Dialysis (No): Failure
    14
    25.9%
    Abdominal surgery (Yes): Success
    12
    22.2%
    Abdominal surgery (Yes): Failure
    7
    13%
    Abdominal surgery (No): Success
    14
    25.9%
    Abdominal surgery (No): Failure
    11
    20.4%
    Solid organ transplant (No): Success
    26
    48.1%
    Solid organ transplant (No): Failure
    18
    33.3%
    Renal insufficiency (Yes): Success
    3
    5.6%
    Renal insufficiency (Yes): Failure
    4
    7.4%
    Renal insufficiency (No): Success
    23
    42.6%
    Renal insufficiency (No): Failure
    14
    25.9%
    Chemotherapy (Yes): Success
    1
    1.9%
    Chemotherapy (Yes): Failure
    0
    0%
    Chemotherapy (No): Success
    25
    46.3%
    Chemotherapy (No): Failure
    18
    33.3%
    Pancreatitis (Yes): Success
    2
    3.7%
    Pancreatitis (Yes): Failure
    3
    5.6%
    Pancreatitis (No): Success
    24
    44.4%
    Pancreatitis (No): Failure
    15
    27.8%
    Systemic steroids/immunos (Yes): Success
    7
    13%
    Systemic steroids/immunos (Yes): Failure
    5
    9.3%
    Systemic steroids/immunos (No): Success
    19
    35.2%
    Systemic steroids/immunos (No): Failure
    13
    24.1%
    Neutropenic: Success
    2
    3.7%
    Neutropenic: Failure
    1
    1.9%
    Non-neutropenic: Success
    18
    33.3%
    Non-neutropenic: Failure
    11
    20.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments ICU stay ≥ 4 days (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 56.3
    Confidence Interval (2-Sided) 95%
    39.1 to 73.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments ICU stay ≥ 4 days (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 66.7
    Confidence Interval (2-Sided) 95%
    40.0 to 93.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Mechanical ventilation (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 54.5
    Confidence Interval (2-Sided) 95%
    37.6 to 71.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Mechanical ventilation (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 72.7
    Confidence Interval (2-Sided) 95%
    46.4 to 99.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Antibiotics (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 56.4
    Confidence Interval (2-Sided) 95%
    40.8 to 72.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Antibiotics (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 80.0
    Confidence Interval (2-Sided) 95%
    44.9 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments CV Catheter (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 55.3
    Confidence Interval (2-Sided) 95%
    39.5 to 71.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments CV Catheter (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 83.3
    Confidence Interval (2-Sided) 95%
    53.5 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments TPN (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 46.2
    Confidence Interval (2-Sided) 95%
    19.1 to 73.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments TPN (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 64.5
    Confidence Interval (2-Sided) 95%
    47.7 to 81.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Dialysis (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 42.9
    Confidence Interval (2-Sided) 95%
    6.2 to 79.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Dialysis (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 62.2
    Confidence Interval (2-Sided) 95%
    46.5 to 77.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Abdominal surgery (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 63.2
    Confidence Interval (2-Sided) 95%
    41.5 to 84.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Abdominal surgery (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 56.0
    Confidence Interval (2-Sided) 95%
    36.5 to 75.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Solid organ transplant (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 59.1
    Confidence Interval (2-Sided) 95%
    44.6 to 73.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Renal insufficiency (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 42.9
    Confidence Interval (2-Sided) 95%
    6.2 to 79.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Renal insufficiency (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 62.2
    Confidence Interval (2-Sided) 95%
    46.5 to 77.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Chemotherapy (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 58.1
    Confidence Interval (2-Sided) 95%
    43.4 to 72.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Pancreatitis (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 40.0
    Confidence Interval (2-Sided) 95%
    0.0 to 82.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Pancreatitis (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 61.5
    Confidence Interval (2-Sided) 95%
    46.3 to 76.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Systemic steroids/immunos (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 58.3
    Confidence Interval (2-Sided) 95%
    30.4 to 86.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Systemic steroids/immunos (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 59.4
    Confidence Interval (2-Sided) 95%
    42.4 to 76.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Neutropenic: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 66.7
    Confidence Interval (2-Sided) 95%
    13.3 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Non-neutropenic: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 62.1
    Confidence Interval (2-Sided) 95%
    44.4 to 79.7
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    8. Secondary Outcome
    Title Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up
    Description Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.
    Time Frame Baseline, Week 2 Follow-up (F/U)

    Outcome Measure Data

    Analysis Population Description
    MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data insufficient for analysis by status=elderly >65 years of age; not summarized.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    ICU stay ≥ 4 days (Yes): Success
    12
    22.2%
    ICU stay ≥ 4 days (Yes): Failure
    20
    37%
    ICU stay ≥ 4 days (No): Success
    9
    16.7%
    ICU stay ≥ 4 days (No): Failure
    3
    5.6%
    Mechanical ventilation (Yes): Success
    13
    24.1%
    Mechanical ventilation (Yes): Failure
    20
    37%
    Mechanical ventilation (No): Success
    8
    14.8%
    Mechanical ventilation (No): Failure
    3
    5.6%
    Antibiotics (Yes): Success
    19
    35.2%
    Antibiotics (Yes): Failure
    20
    37%
    Antibiotics (No): Success
    2
    3.7%
    Antibiotics (No): Failure
    3
    5.6%
    CV Catheter (Yes): Success
    18
    33.3%
    CV Catheter (Yes): Failure
    20
    37%
    CV Catheter (No): Success
    3
    5.6%
    CV Catheter (No): Failure
    3
    5.6%
    TPN (Yes): Success
    5
    9.3%
    TPN (Yes): Failure
    8
    14.8%
    TPN (No): Success
    16
    29.6%
    TPN (No): Failure
    15
    27.8%
    Dialysis (Yes): Success
    1
    1.9%
    Dialysis (Yes): Failure
    6
    11.1%
    Dialysis (No): Success
    20
    37%
    Dialysis (No): Failure
    17
    31.5%
    Abdominal surgery (Yes): Success
    8
    14.8%
    Abdominal surgery (Yes): Failure
    11
    20.4%
    Abdominal surgery (No): Success
    13
    24.1%
    Abdominal surgery (No): Failure
    12
    22.2%
    Solid organ transplant (No): Success
    21
    38.9%
    Solid organ transplant (No): Failure
    23
    42.6%
    Renal insufficiency (Yes): Success
    1
    1.9%
    Renal insufficiency (Yes): Failure
    6
    11.1%
    Renal insufficiency (No): Success
    20
    37%
    Renal insufficiency (No): Failure
    17
    31.5%
    Chemotherapy (Yes): Success
    1
    1.9%
    Chemotherapy (Yes): Failure
    0
    0%
    Chemotherapy (No): Success
    20
    37%
    Chemotherapy (No): Failure
    23
    42.6%
    Pancreatitis (Yes): Success
    2
    3.7%
    Pancreatitis (Yes): Failure
    3
    5.6%
    Pancreatitis (No): Success
    19
    35.2%
    Pancreatitis (No): Failure
    20
    37%
    Systemic steroids/immunos (Yes): Success
    5
    9.3%
    Systemic steroids/immunos (Yes): Failure
    7
    13%
    Systemic steroids/immunos (No): Success
    16
    29.6%
    Systemic steroids/immunos (No): Failure
    16
    29.6%
    Neutropenic: Success
    2
    3.7%
    Neutropenic: Failure
    1
    1.9%
    Non-neutropenic: Success
    15
    27.8%
    Non-neutropenic: Failure
    14
    25.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments ICU stay ≥ 4 days (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 37.5
    Confidence Interval (2-Sided) 95%
    20.7 to 54.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments ICU stay ≥ 4 days (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 75.0
    Confidence Interval (2-Sided) 95%
    50.5 to 99.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Mechanical ventilation (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 39.4
    Confidence Interval (2-Sided) 95%
    22.7 to 56.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Mechanical ventilation (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 72.7
    Confidence Interval (2-Sided) 95%
    46.4 to 99.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Antibiotics (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 48.7
    Confidence Interval (2-Sided) 95%
    33.0 to 64.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Antibiotics (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 40.0
    Confidence Interval (2-Sided) 95%
    0.0 to 82.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments CV Catheter (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 47.4
    Confidence Interval (2-Sided) 95%
    31.5 to 63.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments CV Catheter (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 50.0
    Confidence Interval (2-Sided) 95%
    10.0 to 90.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments TPN (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 38.5
    Confidence Interval (2-Sided) 95%
    12.0 to 64.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments TPN (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 51.6
    Confidence Interval (2-Sided) 95%
    34.0 to 69.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Dialysis (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 14.3
    Confidence Interval (2-Sided) 95%
    0.0 to 40.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Dialysis (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 54.1
    Confidence Interval (2-Sided) 95%
    38.0 to 70.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Abdominal surgery (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 42.1
    Confidence Interval (2-Sided) 95%
    19.9 to 64.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Abdominal surgery (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 52.0
    Confidence Interval (2-Sided) 95%
    32.4 to 71.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Solid organ transplant (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 47.7
    Confidence Interval (2-Sided) 95%
    33.0 to 62.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Renal insufficiency (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 14.3
    Confidence Interval (2-Sided) 95%
    0.0 to 40.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Renal insufficiency (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 54.1
    Confidence Interval (2-Sided) 95%
    38.0 to 70.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Chemotherapy (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 46.5
    Confidence Interval (2-Sided) 95%
    31.6 to 61.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Pancreatitis (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 40.0
    Confidence Interval (2-Sided) 95%
    0.0 to 82.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Pancreatitis (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 48.7
    Confidence Interval (2-Sided) 95%
    33.0 to 64.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Systemic steroids/immunos (Yes): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 41.7
    Confidence Interval (2-Sided) 95%
    13.8 to 69.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Systemic steroids/immunos (No): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 50.0
    Confidence Interval (2-Sided) 95%
    32.7 to 67.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Neutropenic: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 66.7
    Confidence Interval (2-Sided) 95%
    13.3 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments Non-neutropenic: Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 51.7
    Confidence Interval (2-Sided) 95%
    33.5 to 69.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    9. Secondary Outcome
    Title Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score
    Description Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score <20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.
    Time Frame EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    APACHE <20 (EIVT): Success
    24
    44.4%
    APACHE <20 (EIVT): Failure
    11
    20.4%
    APACHE ≥20 (EIVT): Success
    2
    3.7%
    APACHE ≥20 (EIVT): Failure
    7
    13%
    APACHE <20 (EOT): Success
    25
    46.3%
    APACHE <20 (EOT): Failure
    10
    18.5%
    APACHE ≥20 (EOT): Success
    1
    1.9%
    APACHE ≥20 (EOT): Failure
    8
    14.8%
    APACHE <20 (Week 2 F/U): Success
    20
    37%
    APACHE <20 (Week 2 F/U): Failure
    15
    27.8%
    APACHE ≥20 (Week 2 F/U): Success
    1
    1.9%
    APACHE ≥20 (Week 2 F/U): Failure
    8
    14.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments APACHE <20 (EIVT): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 68.6
    Confidence Interval (2-Sided) 95%
    53.2 to 84.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments APACHE ≥20 (EIVT): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 22.2
    Confidence Interval (2-Sided) 95%
    0.0 to 49.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments APACHE <20 (EOT): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 71.4
    Confidence Interval (2-Sided) 95%
    56.5 to 86.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments APACHE ≥20 (EOT): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 11.1
    Confidence Interval (2-Sided) 95%
    0.0 to 31.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments APACHE <20 (Week 2 F/U): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 57.1
    Confidence Interval (2-Sided) 95%
    40.7 to 73.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Anidulafungin-Voriconazole
    Comments APACHE ≥20 (Week 2 F/U): Success
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter percentage of participants with success
    Estimated Value 11.1
    Confidence Interval (2-Sided) 95%
    0.0 to 31.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments 95% CI based on normal approximation to the binomial.
    10. Secondary Outcome
    Title Number of Participants Per Survival Status (Alive or Dead) on Day 30
    Description
    Time Frame Day 30

    Outcome Measure Data

    Analysis Population Description
    MITT
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    Alive
    25
    46.3%
    Dead
    19
    35.2%
    11. Secondary Outcome
    Title Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis
    Description Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded "disease under study" as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone.
    Time Frame Baseline to Week 6 Follow-up

    Outcome Measure Data

    Analysis Population Description
    MITT. MITT. Death for 1 participant reported twice in this study(recorded at End of Treatment and at End of Study); both instances are reported in this table under Attributal Death=No.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 44
    Attributable death (Yes)
    4
    7.4%
    Attributable death (No)
    19
    35.2%
    12. Secondary Outcome
    Title Time to Negative Blood, Specimen, or Tissue Culture
    Description Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).
    Time Frame Baseline to Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    MITT; data not summarized using descriptive statistics.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 0
    13. Secondary Outcome
    Title Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment
    Description Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.
    Time Frame Baseline to Day 42

    Outcome Measure Data

    Analysis Population Description
    Safety analysis set: all participants who received any dose of study medication.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 54
    Median (Full Range) [days]
    10.0
    14. Secondary Outcome
    Title Length of Hospital Stay
    Description Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.
    Time Frame Baseline to Week 6 Follow-up

    Outcome Measure Data

    Analysis Population Description
    MITT; data not summarized using descriptive statistics.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 0
    15. Secondary Outcome
    Title Length of Stay in Intensive Care Unit (ICU)
    Description Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.
    Time Frame Baseline up to Week 6 Follow-up

    Outcome Measure Data

    Analysis Population Description
    MITT; N=number of participants evaluable for length of time in ICU.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 32
    Median (95% Confidence Interval) [Days]
    16.0
    16. Secondary Outcome
    Title Change From Baseline in Vital Signs: Supine Blood Pressure
    Description Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).
    Time Frame Baseline to Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 54
    Baseline median: supine systolic BP
    120.0
    Change from baseline: supine systolic BP
    0.00
    Baseline median: supine diastolic BP
    66.0
    Change from baseline: supine diastolic BP
    0.00
    17. Secondary Outcome
    Title Change From Baseline in Vital Signs: Supine Heart Rate
    Description Supine heart rate measured as beats per minute (bpm).
    Time Frame Baseline to Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 54
    Baseline median: supine heart rate
    97.5
    Change from baseline: supine heart rate
    3.00
    18. Secondary Outcome
    Title Change From Baseline in Vital Signs: Weight
    Description Weight measured as kilograms (kg).
    Time Frame Baseline to Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population; N=number of participants with evaluable data.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 30
    Baseline median: weight
    65.0
    Change from baseline: weight
    -0.70
    19. Secondary Outcome
    Title Change From Baseline in Vital Signs: Temperature
    Description Temperature measured as degrees of Celsius (C).
    Time Frame Baseline to Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 54
    Baseline median: temperature
    37.5
    Change from baseline: temperature
    -0.30
    20. Secondary Outcome
    Title Change From Baseline in Vital Signs: Respiration Rate
    Description Respiration rate measured as respirations per minute (resp/min).
    Time Frame Baseline to Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 54
    Baseline median: respiration rate
    20.0
    Change from baseline: respiration rate
    -0.50
    21. Secondary Outcome
    Title Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)
    Description Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).
    Time Frame Baseline to Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 27
    Baseline median: total bilirubin (n=19)
    0.6
    Change from baseline: total bilirubin
    -0.2
    Baseline median: direct bilirubin (n=19)
    0.2
    Change from baseline: direct bilirubin
    -0.1
    Baseline median: indirect bilirubin (n=17)
    0.3
    Change from baseline: indirect bilirubin
    0.0
    Baseline median: blood urea nitrogen (n=25)
    37.4
    Change from baseline: blood urea nitrogen
    -4.8
    Baseline median: creatinine (n=27)
    0.8
    Change from baseline: creatinine
    0.0
    Baseline median: glucose (n=24)
    99
    Change from baseline: glucose
    -6
    22. Secondary Outcome
    Title Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)
    Description Chemistry laboratory test data measured as international units per (IU/L).
    Time Frame Baseline to Week 2 Follow-up

    Outcome Measure Data

    Analysis Population Description
    Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    Measure Participants 18
    Baseline median: aspartate aminotransferase (n=18)
    43
    Change from baseline: aspartate aminotransferase
    -18
    Baseline median: alanine aminotransferase (n=16)
    45
    Change from baseline: alanine aminotransferase
    -5
    Baseline median: lactate dehydrogenase (n=13)
    536
    Change from baseline: lactate dehydrogenase
    -160
    Baseline median: alkaline phosphatase (n=17)
    114
    Change from baseline: alkaline phosphatase
    26

    Adverse Events

    Time Frame
    Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Arm/Group Title Anidulafungin-Voriconazole
    Arm/Group Description Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
    All Cause Mortality
    Anidulafungin-Voriconazole
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Anidulafungin-Voriconazole
    Affected / at Risk (%) # Events
    Total 29/54 (53.7%)
    Blood and lymphatic system disorders
    Blood disorder 1/54 (1.9%)
    Cardiac disorders
    Acute myocardial infarction 1/54 (1.9%)
    Atrial fibrillation 1/54 (1.9%)
    Cardiac arrest 2/54 (3.7%)
    Cardio-respiratory arrest 4/54 (7.4%)
    Supraventricular tachycardia 1/54 (1.9%)
    Ventricular arrhythmia 1/54 (1.9%)
    Ventricular tachycardia 1/54 (1.9%)
    Gastrointestinal disorders
    Intestinal perforation 1/54 (1.9%)
    Pancreatic insufficiency 1/54 (1.9%)
    General disorders
    Death 3/54 (5.6%)
    Drug ineffective 1/54 (1.9%)
    Multi-organ disorder 4/54 (7.4%)
    Pyrexia 1/54 (1.9%)
    Hepatobiliary disorders
    Hepatic failure 1/54 (1.9%)
    Infections and infestations
    Abdominal sepsis 1/54 (1.9%)
    Abdominal wall abscess 1/54 (1.9%)
    Cellulitis 1/54 (1.9%)
    Endocarditis 1/54 (1.9%)
    Fusarium infection 1/54 (1.9%)
    Pelvic infection 1/54 (1.9%)
    Pneumonia 1/54 (1.9%)
    Pneumonia klebsiella 1/54 (1.9%)
    Pulmonary sepsis 1/54 (1.9%)
    Septic shock 11/54 (20.4%)
    Injury, poisoning and procedural complications
    Anastomotic leak 1/54 (1.9%)
    Failure to anastomose 1/54 (1.9%)
    Gastrointestinal stoma complication 1/54 (1.9%)
    Post procedural fistula 1/54 (1.9%)
    Wound dehiscence 1/54 (1.9%)
    Metabolism and nutrition disorders
    Hyperkalaemia 1/54 (1.9%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Leukaemia recurrrent 1/54 (1.9%)
    Nervous system disorders
    Convulsion 1/54 (1.9%)
    Partial seizures 1/54 (1.9%)
    Renal and urinary disorders
    Anuria 1/54 (1.9%)
    Renal failure 2/54 (3.7%)
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 1/54 (1.9%)
    Acute respiratory failure 3/54 (5.6%)
    Lung disorder 1/54 (1.9%)
    Obstructive airways disorder 1/54 (1.9%)
    Pneumonia aspiration 1/54 (1.9%)
    Pneumothorax 1/54 (1.9%)
    Respiratory failure 1/54 (1.9%)
    Vascular disorders
    Arterial thrombosis 1/54 (1.9%)
    Circulatory collapse 1/54 (1.9%)
    Hypotension 2/54 (3.7%)
    Hypovolaemic shock 1/54 (1.9%)
    Lupus vasculitis 1/54 (1.9%)
    Shock 1/54 (1.9%)
    Shock haemorrhagic 2/54 (3.7%)
    Other (Not Including Serious) Adverse Events
    Anidulafungin-Voriconazole
    Affected / at Risk (%) # Events
    Total 26/54 (48.1%)
    Blood and lymphatic system disorders
    Anaemia 5/54 (9.3%)
    Leukopenia 3/54 (5.6%)
    Thrombocytopenia 3/54 (5.6%)
    Gastrointestinal disorders
    Diarrhoea 3/54 (5.6%)
    Vomiting 3/54 (5.6%)
    General disorders
    Pyrexia 4/54 (7.4%)
    Metabolism and nutrition disorders
    Hyperglycaemia 3/54 (5.6%)
    Hyperkalaemia 3/54 (5.6%)
    Hypokalaemia 10/54 (18.5%)
    Skin and subcutaneous tissue disorders
    Rash 3/54 (5.6%)
    Vascular disorders
    Hypertension 4/54 (7.4%)
    Hypotension 3/54 (5.6%)

    Limitations/Caveats

    Protocol registration indicated timeframes for EIVT and/or Week 2 F/U for time to event, mortality, vital signs, and labs; however, analyses were continuous and reported from baseline to EIVT (up to Day 42), Week 2 F/U, or Week 6 telephone F/U visit.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00548262
    Other Study ID Numbers:
    • A8851015
    First Posted:
    Oct 23, 2007
    Last Update Posted:
    Jan 17, 2011
    Last Verified:
    Dec 1, 2010