Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01202253
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 2.9
• Patients Per Site Per Month: 17.1

Study Details

Study Description

Brief Summary

The purpose of this study is to describe the real world effectiveness of anidulafungin in clinical practice in a large Liver Unit in the United Kingdom.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis	Drug: anidulafungin

Detailed Description

All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Study To Describe The Early Clinical Experience With Anidulafungin In Patients With Liver Disease At King's College Hospital NHS Trust, London
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Anidulafungin	Drug: anidulafungin; A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.; Other Names: ECALTA, ERAXIS

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Favorable Outcome [Day 28 post-treatment]

   Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.

Secondary Outcome Measures

1. Percentage of Participants With Unfavorable Outcome [Day 28 post-treatment]

   Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.

2. Percentage of Participants Who Died Due to All Causes [Baseline up to Day 28 post-treatment]

   Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.

3. Percentage of Participants With Death Attributable to Fungal Infection [Baseline up to Day 28 post-treatment]

4. Percentage of Participants With Death Unrelated to Fungal Infection [Baseline up to Day 28 post-treatment]

5. Percentage of Participants With Favorable Clinical Response [Day 28 post-treatment]

   Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.

6. Percentage of Participants With Lack of Clinical Response [Day 28 post-treatment]

   Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.

7. Percentage of Participants Requiring Change or Additional Antifungal Therapy [Baseline up to Day 28 post-treatment]

   Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

8. Percentage of Participants With Oral Antifungal Started to Complete Therapy [Baseline up to Day 28 post-treatment]

9. Percentage of Participants With Documented Eradication of Infecting Species [Baseline]

   Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.

10. Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results [Baseline up to Day 28 post-treatment]

    An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.

11. Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results [Baseline up to Day 28 post-treatment]

    A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.

12. Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy [Baseline]

    Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).

13. Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy [Day 28 post-treatment]

    Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.

14. Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy [Baseline up to Day 28 post-treatment]

    Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.

15. Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy [Baseline up to Day 28 post-treatment]

16. Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU) [Baseline]

17. Duration of Stay at Liver Intensive Therapy Unit (LITU) [Baseline up to Day 28 post-treatment]

18. Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3 [Baseline]

    Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).

19. Percentage of Participants With Concomitant Bacterial or Viral Infection [Baseline]

    Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).

20. Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start [Baseline]

    Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

21. Dose Changes for Immunosuppressant Drugs [Baseline up to Day 28 post-treatment]

22. Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy [Baseline]

23. Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy [Baseline]

    Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).

24. Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy [Baseline]

    Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

25. Number of Participants With Infection Sites as Per Microbiological Analysis [Baseline]

    Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.

26. Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan [Baseline]

27. Infecting Organisms by Species [Baseline up to Day 14 post-treatment]

28. Percentage of Participants With Prior Colonization With Candida by Species [Baseline]

    Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).

29. Percentage of Participants With Prior Colonization With Candida by Colonization Index [Baseline]

30. Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index [Baseline]

31. Number of Participants Who Received Water-based and Ethanol-based Formulation [Baseline]

32. Percentage of Participants Who Received Water-based and Ethanol-based Formulation [Baseline]

33. Percentage of Participants Who Received 200 mg Loading Dose [Day 1]

34. Percentage of Participants Who Received 100 mg Dose on Day 2 [Day 2]

35. Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses [Baseline up to Day 28 post-treatment]

36. Number of Participants With Other Dosing Patterns [Baseline up to Day 28 post-treatment]

    The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.

37. Duration of Anidulafungin Therapy [Baseline]

38. Number of Serious Adverse Events (SAEs) [Baseline up to Day 28 post-treatment]

    Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

39. Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs) [Baseline up to Day 28 post-treatment]

40. Number of Participants With Different Types of Drug-related Serious Adverse Events [Baseline up to Day 28 post-treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects who have been prescribed anidulafungin between 1st July 2009 and 30th September 2010.

Patients admitted to specialist liver unit wards and the Liver Intensive Therapy Unit during this period

Exclusion Criteria:

• Patients who participated in any interventional clinical trial during this episode of sepsis.

Patients who received anidulafungin for infection prophylaxis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	London		United Kingdom	SE5 9RS

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01202253
• Other Study ID Numbers: A8851028
• First Posted: Sep 15, 2010
• Last Update Posted: Apr 16, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Pfizer: Ecalta; Eraxis; Candida; Candidemia; Systemic Candidiasis; ICU; Intensive Care Unit; Critical Care Unit
• Additional relevant MeSH terms: Candidiasis; Liver Diseases; Anidulafungin

Study Results

Participant Flow

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Period Title: Overall Study
STARTED	50
COMPLETED	50
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Overall Participants	50
Age, Customized (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	50.5 (16.4)
Sex: Female, Male (Count of Participants)
Female	20 40%
Male	30 60%
Percentage of participants with elective or emergency hospital admission (percentage of participants) [Number]
Elective admission	72 144%
Emergency admission	28 56%
Overall duration of hospital stay (days) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [days]	86.46
Number of participants with underlying liver disease (participants) [Number]
Acute liver disease	1 2%
Chronic liver disease	8 16%
Chronic and acute liver disease	3 6%
Hepatopancreaticobiliary disease	12 24%
Hepatopancreaticobiliary disease, pancreatitis	3 6%
Liver transplant	4 8%
Liver transplant, acute liver disease	3 6%
Liver transplant, acute liver failure	1 2%
Liver transplant, acute liver disease, failure	1 2%
Liver transplant, chronic liver disease	11 22%
Liver transplant, chronic disease, acute failure	1 2%
Liver transplant, chronic disease, pancreatitis	1 2%
Liver laceration	1 2%
Number of participants with relevant co-morbidities (participants) [Number]
History of alcohol abuse	19 38%
Diabetes	18 36%
Hepatitis C	5 10%
Malignancy	12 24%
Other	37 74%
Number of participants with markers of illness severity (participants) [Number]
Upper gastrointestinal (GI) bleed	21 42%
Central line of admission	25 50%
Total parenteral nutrition	26 52%
Intubated on admission	15 30%
Major surgery	37 74%
Renal failure	31 62%
Percentage of participants with Model for End-Stage Liver Disease (MELD) score (percentage of participants) [Number]
Less than 10	7 14%
10 to 19	13 26%
20 to 29	37 74%
30 to 39	37 74%
Greater than or equal to 40	7 14%
Number of participants with disease severity score (participants) [Number]
Number [participants]	NA NaN
Number of participants with total white cell count (participants) [Number]
Less than 4 * 10^9/Liter	8 16%
4 to 11 * 10^9/Liter	3 6%
Greater than 11 * 10^9/Liter	39 78%
Number of participants with International Normalized Ratio (INR) results (participants) [Number]
Less than 0.8	0 0%
0.8 to 1.6	32 64%
Greater than 1.6	18 36%
Number of participants with C-reactive protein (CRP) levels (participants) [Number]
Less than 5 mg/liter (mg/L)	2 4%
Greater than or equal to 5 mg/L	44 88%
Not done	4 8%
Number of participants with urea levels (participants) [Number]
Less than 3.3 millimole/Liter (mmol/L)	1 2%
3.3 to 6.7 mmol/L	15 30%
Greater than 6.7 mmol/L	34 68%
Percentage of participants with creatinine clearance outside normal range (percentage of participants) [Number]
Number [percentage of participants]	NA NaN
Percentage of participants prescribed with immunosuppressant drugs (percentage of participants) [Number]
Azathioprine	2 4%
Ciclosporin	2 4%
Methylprednisolone	2 4%
Prednisolone	44 88%
Tacrolimus or tacrolimus modified release (MR)	50 100%
Percentage of participants prescribed with concomitant systemic antifungals (percentage of participants) [Number]
Amphotericin	2 4%
Fluconazole	12 24%
Percentage of participants prescribed with concomitant antibiotics (percentage of participants) [Number]
Amikacin	22 44%
Ciprofloxacin	2 4%
Clarithromycin	2 4%
Colistin	4 8%
Co-trimoxazole	8 16%
Erythromycin	4 8%
Gentamicin	4 8%
Linezolid	28 56%
Metronidazole	4 8%
Tazocin	34 68%
Vancomycin	38 76%
Number of participants with concomitant antibiotics prescribed (participants) [Number]
0 antibiotic	4 8%
1 antibiotic	8 16%
2 antibiotics	22 44%
3 antibiotics	8 16%
4 antibiotics	7 14%
5 antibiotics	1 2%
Duration of antibiotic course (days) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [days]	16.00
Percentage of participants prescribed with antiviral courses (percentage of participants) [Number]
Aciclovir	2 4%
Ganciclovir	6 12%
Oseltamivir	2 4%
Valganciclovir	20 40%
Duration of antiviral courses (days) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [days]	NA

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Favorable Outcome
Description	Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.
Time Frame	Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	76.1 152.2%

2. Secondary Outcome

Title	Percentage of Participants With Unfavorable Outcome
Description	Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.
Time Frame	Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	23.9 47.8%

3. Secondary Outcome

Title	Percentage of Participants Who Died Due to All Causes
Description	Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	38.0 76%

4. Secondary Outcome

Title	Percentage of Participants With Death Attributable to Fungal Infection
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number [percentage of participants]	0 0%

5. Secondary Outcome

Title	Percentage of Participants With Death Unrelated to Fungal Infection
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	36.0 72%

6. Secondary Outcome

Title	Percentage of Participants With Favorable Clinical Response
Description	Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.
Time Frame	Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	80.4 160.8%

7. Secondary Outcome

Title	Percentage of Participants With Lack of Clinical Response
Description	Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.
Time Frame	Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	46
Number (95% Confidence Interval) [percentage of participants]	19.6 39.2%

8. Secondary Outcome

Title	Percentage of Participants Requiring Change or Additional Antifungal Therapy
Description	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Due to all reasons	16.0 32%
Due to lack of clinical response	4.0 8%
Due to adverse event	0.0 0%

9. Secondary Outcome

Title	Percentage of Participants With Oral Antifungal Started to Complete Therapy
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	32.0 64%

10. Secondary Outcome

Title	Percentage of Participants With Documented Eradication of Infecting Species
Description	Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Data was not analyzed as the study was retrospective and data for eradication of candida infection was not documented in the participants' medical notes.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	0

11. Secondary Outcome

Title	Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results
Description	An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	80.0 160%

12. Secondary Outcome

Title	Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results
Description	A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator's discretion.
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	68.0 136%

13. Secondary Outcome

Title	Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy
Description	Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	98.0 196%

14. Secondary Outcome

Title	Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy
Description	Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.
Time Frame	Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	74.0 148%

15. Secondary Outcome

Title	Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy
Description	Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Bilirubin test	24.0 48%
Aspartate transaminase test	40.0 80%
Alkaline phosphatase test	34.0 68%
Gamma glutamyl transferase test	36.0 72%

16. Secondary Outcome

Title	Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Data was not analyzed as the study was retrospective and data for creatinine clearance was not available for the participants.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	0

17. Secondary Outcome

Title	Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	78.0 156%

18. Secondary Outcome

Title	Duration of Stay at Liver Intensive Therapy Unit (LITU)
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	39
Mean (Inter-Quartile Range) [days]	29.38

19. Secondary Outcome

Title	Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3
Description	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Less than 500/mm^3	2.0 4%
Greater than or equal to 500/mm^3	98.0 196%

20. Secondary Outcome

Title	Percentage of Participants With Concomitant Bacterial or Viral Infection
Description	Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Bacterial infection	96.0 192%
Viral infection	46.0 92%

21. Secondary Outcome

Title	Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start
Description	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Amphotericin	4.0 8%
Caspofungin	4.0 8%
Fluconazole	70.0 140%

22. Secondary Outcome

Title	Dose Changes for Immunosuppressant Drugs
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Data was not analyzed as the study was retrospective and data for dose change for immunosuppressant drugs was not available.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	0

23. Secondary Outcome

Title	Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Probable fungal infection	28.0 56%
Proven fungal infection	72.0 144%

24. Secondary Outcome

Title	Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy
Description	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Above 38.0 degree Celsius	98.0 196%
Below 36.0 degree Celsius	2.0 4%

25. Secondary Outcome

Title	Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy
Description	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	4.0 8%

26. Secondary Outcome

Title	Number of Participants With Infection Sites as Per Microbiological Analysis
Description	Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Blood only	4 8%
Blood and chest	1 2%
Blood and urinary tract	2 4%
Chest only	3 6%
Intra-abdominal	13 26%
Intra-abdominal and bile duct	3 6%
Intra-abdominal and blood	4 8%
Intra-abdominal, chest and liver	1 2%
Intra-abdominal and kidney	1 2%
Intra-abdominal and liver	2 4%
Liver only	1 2%
Liver and urinary tract	1 2%
Esophagus and mouth	1 2%
Urinary tract and chest	1 2%
Urinary tract and esophagus	1 2%

27. Secondary Outcome

Title	Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Data was not analyzed as the study was retrospective and data for infection site as per ultrasound and CT scan was not available.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	0

28. Secondary Outcome

Title	Infecting Organisms by Species
Time Frame	Baseline up to Day 14 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Candida albicans	17 34%
Candida glabrata	17 34%
Candida guilliermondii	3 6%
Candida krusei	2 4%
Candida parapsilosis	3 6%
Candida species (spp)	16 32%
Candida spp (non Candida albicans)	1 2%
Candida tropicalis	1 2%
Fusarium dimerum	1 2%
Saccharomyces cerevisiae	2 4%
Yeast	2 4%
Adenovirus	1 2%
Citrobacter	2 4%
Clostridium difficile	3 6%
Cytomegalovirus (CMV)	9 18%
Escherichia coli	5 10%
Escherichia faecalis	4 8%
Escherichia faecium	4 8%
Epstein-Barr virus (EBV)	3 6%
Elizabeth meningoseptica cum chrysobacterium	1 2%
Enterobacter cloacae	1 2%
Enterobacter spp	3 6%
Hemagglutinin 1 Neuraminidase 1 (H1N1)- swine flu	3 6%
Herpes simplex virus type 1	2 4%
Klebsiella oxytoca	1 2%
Klebsiella pneumonia	1 2%
Klebsiella spp	4 8%
Methicillin-resistent Staphylococcus aureus	1 2%
Pneumocystic jiroveci	1 2%
Pseudomonas spp	5 10%
Respiratory syncytial virus	1 2%
Rhinovirus	1 2%
Staphylococcus aureus	3 6%
Staphylococcus capitis	1 2%
Stenotrophomonas maltophilia	1 2%
Stenotrophomonas spp	3 6%
Vancomycin-resistant enterococcus	7 14%
Pseudomonas aeruginosa	1 2%
Staphylococcus epidermidis	1 2%

29. Secondary Outcome

Title	Percentage of Participants With Prior Colonization With Candida by Species
Description	Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Candida albicans	16.0 32%
Candida glabrata	10.0 20%
Candida guilliermondii	2.0 4%
Candida spp	12.0 24%
Candida tropicalis	2.0 4%
Candida species unknown	6.0 12%

30. Secondary Outcome

Title	Percentage of Participants With Prior Colonization With Candida by Colonization Index
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Data for prior colonization by colonization index was not analyzed as the study was retrospective and colonization index was not recorded for the participants.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	0

31. Secondary Outcome

Title	Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number [percentage of participants]	0 0%

32. Secondary Outcome

Title	Number of Participants Who Received Water-based and Ethanol-based Formulation
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Water based formulation	16 32%
Ethanol based formulation	34 68%

33. Secondary Outcome

Title	Percentage of Participants Who Received Water-based and Ethanol-based Formulation
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Water based formulation	32.0 64%
Ethanol based formulation	68.0 136%

34. Secondary Outcome

Title	Percentage of Participants Who Received 200 mg Loading Dose
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	100.0 200%

35. Secondary Outcome

Title	Percentage of Participants Who Received 100 mg Dose on Day 2
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	100.0 200%

36. Secondary Outcome

Title	Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	100.0 200%

37. Secondary Outcome

Title	Number of Participants With Other Dosing Patterns
Description	The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number [participants]	0 0%

38. Secondary Outcome

Title	Duration of Anidulafungin Therapy
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Mean (Standard Deviation) [days]	17.96 (11.04)

39. Secondary Outcome

Title	Number of Serious Adverse Events (SAEs)
Description	Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number [events]	5

40. Secondary Outcome

Title	Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number [percentage of participants]	0 0%

41. Secondary Outcome

Title	Number of Participants With Different Types of Drug-related Serious Adverse Events
Time Frame	Baseline up to Day 28 post-treatment

Outcome Measure Data

Analysis Population Description

Full analysis set included all participants who met the defined eligibility criteria.

Arm/Group Title	Anidulafungin
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
Measure Participants	50
Number [participants]	0 0%

Adverse Events

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
Arm/Group Description	Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
All Cause Mortality
	Anidulafungin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Anidulafungin
	Affected / at Risk (%)	# Events
Total	5/50 (10%)
General disorders
New Candida parapsilosis infection	1/50 (2%)
Breakthrough Candida glabrata infection	2/50 (4%)
Breakthrough Candida parapsilosis infection	1/50 (2%)
Continuing Candida glabrata infection	1/50 (2%)
Other (Not Including Serious) Adverse Events
	Anidulafungin
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

Protocol-specified endpoint, percentage of participants with presumed eradication of infecting species, was not presented as a separate outcome measure because the 'presumed eradication' was considered same as favorable clinical response.

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.