STRIVE: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension

Sponsor
Cidara Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02734862
Collaborator
(none)
207
63
3
35.2
3.3
0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if intravenous CD101 is safe and effective in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This Bridging Extension is to determine if intravenous CD101 is safe [Day 45- 52 for subjects with candidemia only, or Day 52- 59 for subjects with invasive candidiasis with or without candidemia] and effective [Day 14 (± 1 day)] in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).

Study Design

Study Type:
Interventional
Actual Enrollment :
207 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Randomized, Double-blind Study of the Safety, Tolerability, and Efficacy of Intravenous CD101 vs Intravenous Caspofungin Followed by Oral Fluconazole Step-down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
Actual Study Start Date :
Jul 26, 2016
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.

Drug: CD101
Intravenous antifungal therapy
Other Names:
  • CD101 for Injection
  • Drug: intravenous placebo
    normal saline
    Other Names:
  • placebo infusion
  • Drug: oral placebo
    microcrystalline cellulose
    Other Names:
  • encapsulated cellulose
  • Active Comparator: Group 3

    Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind.

    Drug: Caspofungin
    Intravenous antifungal therapy
    Other Names:
  • Cancidas
  • Drug: Fluconazole
    oral antifungal therapy
    Other Names:
  • generic fluconazole
  • Drug: intravenous placebo
    normal saline
    Other Names:
  • placebo infusion
  • Experimental: Group 2

    Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.

    Drug: CD101
    Intravenous antifungal therapy
    Other Names:
  • CD101 for Injection
  • Drug: intravenous placebo
    normal saline
    Other Names:
  • placebo infusion
  • Drug: oral placebo
    microcrystalline cellulose
    Other Names:
  • encapsulated cellulose
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] [From first dose of study drug through Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.]

      Number of Subjects with Incidence of Treatment Emergent Adverse Events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.

    2. Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] [Day 14 (± 1 day)]

      Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline

    Secondary Outcome Measures

    1. Mycological Eradication and Resolution of Systemic Signs [Day 5, and Follow-up (FU Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.]

      Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population.

    2. Mycological Eradication [Day 5, Day 14 (±1 day), and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia)]

      Evaluate mycological success (eradication) in the mITT population.

    3. Clinical Cure [Day 14 (±1 day) and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia).]

      Evaluate clinical cure as assessed by the Investigator in the mITT population. Subjects must meet all of the following requirements: Resolution of attributable systemic signs and symptoms of candidemia/IC that were present at baseline No new systemic signs or symptoms attributable to candidemia/IC No additional systemic antifungal therapy administered for candidemia/IC The subject is alive

    4. Evaluate PK (Cmax) [Day 1, 10 minutes before end of infusion (EOI)]

      Evaluate maximum plasma concentration (Cmax) (Part A only)

    5. Evaluate PK (Cmin) [Day 8, predose]

      Evaluate minimum plasma concentration (Cmin) (Part A only)

    6. Evaluate PK (Cmin) [Day 15, predose]

      Evaluate minimum plasma concentration (Cmin) (Part A only)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken less than or equal to 96 hours before randomization (defined as: at least 1 blood culture positive for Candida or positive test for Candida from a sponsor approved rapid diagnostic test or positive gram stain for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site)

    • willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required. Patients receiving only medications and measures for comfort and not cure should not be enrolled.

    • female subjects of child bearing potential <2 years post menopausal must agree to one barrier method and one highly effective method of birth control or sexual abstinence.

    • male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm from first dose of CD101 (Day 1) until 90 days following last administration of study drug.

    • willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on their behalf.

    • presence of one or more systemic signs attributable to candidemia and/or invasive candidiasis

    Exclusion Criteria:
    • Any of the following forms of IC:
    1. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)

    2. Osteomyelitis

    3. Endocarditis or myocarditis

    4. Meningitis, endophthalmitis, or any central nervous system infection

    • neutropenia

    • alanine aminotransferase or aspartate aminotransferase levels >10 fold the upper limit of normal

    • severe hepatic impairment in subjects with a history of chronic cirrhosis

    • greater than 48 hours systemic antifungal treatment at approved doses to treat candidemia

    • pregnant females

    • lactating females who are nursing

    • known hypersensitivity to CD101, caspofungin, any echinocandin, or to any of their excipients

    • previous participation in this or any previous CD101 study

    • recent use of an investigational medicinal product within 28 days of first dose of study drug or presence of an investigational device at the time of screening

    • Principal Investigator considers the subject should not participate

    • presence of indwelling vascular catheter or device that cannot be removed and is likely to be the source of candidemia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 University of California - Davis Davis California United States 95817
    3 University of Miami Miller School of Medicine Miami Florida United States 33136
    4 Augusta University Augusta Georgia United States 30912
    5 Brigham and Women's Hospital Boston Massachusetts United States 02115
    6 Harper University Hospital Detroit Michigan United States 48201
    7 Henry Ford Health System Detroit Michigan United States 48202
    8 William Beaumont Hospital Royal Oak Michigan United States 48073
    9 University of Mississippi Medical Center Jackson Mississippi United States 39216
    10 Washington University School of Medicine Saint Louis Missouri United States 63110
    11 Mercury Street Medical Butte Montana United States 59701
    12 Albany Medical Center Albany New York United States 12208
    13 Mercy Health - St. Vincent Medical Center - ID Clinical Research Toledo Ohio United States 43608
    14 Reading Hospital and Medical Center West Reading Pennsylvania United States 19611
    15 University of Texas Health Science Center at Houston Houston Texas United States 77030
    16 Virginia Tech, Carillion School of Medicine Roanoke Virginia United States 24016
    17 Jules Bordet Institute Brussels Belgium 1000
    18 CHU Brugman Brussels Belgium 1020
    19 Erasme Hospital Brussels Belgium 1070
    20 UCL Saint-LUC Brussels Belgium 1200
    21 UZ Gent Algemene Inwendige Zietken Gent Belgium 9000
    22 University Hospital Brussels Jette Belgium 1090
    23 University Hospital Leuven Leuven Belgium 3000
    24 CHU Sart-Tillman Liège Belgium 4000
    25 University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology Sofia Bulgaria 1431
    26 University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Burns and Plastic Surgery Clinic, Department of Anesthesiology and Intensive Care Sofia Bulgaria 1606
    27 Juravinski Hospital and Cancer Centre/Hamilton Health Sciences Hamilton Ontario Canada L8V 1C3
    28 Toronto General Hospital-University Health Network Toronto Ontario Canada M5G 2N2
    29 CIUSSS de L'Est-de-l'Île-De-Montréal, Installation Hôpital Montréal Quebec Canada H1T 2M4
    30 McGill University Health Centre-Research Institute Montréal Quebec Canada H4A 3J1
    31 University General Hospital "Attikon", 2nd Department of Critical Care Athens Chaidari Greece 12 462
    32 General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit Athens Greece 10676
    33 Laiko General Hospital of Athens Athens Greece 115 27
    34 Henry Dunant Hospital Center Athens Greece 11526
    35 General Hospital of Athens "Evangelismos", Department of Critical Care Athens Greece
    36 University Hospital of Larissa, Department of Critical Care Unit Thessaloníki Greece 41110
    37 Medical Centre, Hungarian Defence Forces, Central Intensive Care Unit and Anesthesiology Department Budapest Hungary 1134
    38 Fejer County St. Gyorgy University Teaching Hospital, Central Department of Anesthesiology and Intensive Care Unit Szeged Hungary 6725
    39 Polyclinic S. Orsola-Malpighi, Department of Organ Impairment and Transplants, Operative Unit of Infectious Diseases Bologna Italy 40138
    40 University Polyclinic Hospital of Modena, Department of General and Specialist Surgery, Operative Unit of Anesthesia and Intensive Care I Modena Italy 41124
    41 University Hospital of Pisa, Department of Gastroenterology and Infectious Diseases, Operative Unit of Infectious Diseases Pisa Italy 56124
    42 University Polyclinic Agostino Gemelli, Complex Operative Unit of Infectious Diseases 2 Rome Italy 00168
    43 Hospital Maggiore University Hospital Ospedali Riuniti of Trieste Dept of ID Trieste Italy 34125
    44 University Hospital "Santa Maria della Misericordia" of Udine, Department of Specialist Medicine, Clinic of Infectious Diseases Udine Italy 33100
    45 Craiova County Emergency Clinical Hospital, ATI Clinic Craiova Dolj County Romania 200642
    46 Institute of Infectious Diseases Bucharest Sector 2 Romania 021105
    47 Pius Brinzeu County Emergency Clinical Hospital, Anesthesia and Intensive Care Department (Romania) Timişoara Timis County Romania 300723
    48 Sfanta Parascheva Parascheva Iasi Clinical Hospital for Infectious Diseases Iaşi Romania 700116
    49 Kuban State Medical University Krasnodar Russian Federation 350063
    50 Territorial Clinical Hospital Krasnoyarsk Russian Federation 660022
    51 Mariinskaya City Hospital Saint Petersburg Russian Federation 191104
    52 University Hospital Vall d'Hebron (HUVH), Department of Infectious Diseases Barcelona Catalonia Spain 08035
    53 Hospital Clinic i Provincial de Barcelona, Department of Infectious Diseases Barcelona Catalonia Spain 08036
    54 University Hospital Cruces, Unit of Infectious Diseases Barakaldo Spain 48903
    55 Hospital del Mar, Department of Infectious Diseases Barcelona Spain 08003
    56 General University Hospital Gregorio Maranon Madrid Spain 28007
    57 University Hospital Ramon y Cajal Madrid Spain 28034
    58 University Hospital Clinical San Carlos Madrid Spain 28040
    59 University Hospital La Paz Madrid Spain 28046
    60 University Hospital Virgen Macarena Sevilla Spain 41009
    61 University Hospital Nuestra Senora de Valme, Sevilla Spain 41014
    62 University Hospital Virgen del Rocio (HUVR) Sevilla Spain
    63 University Hospital La Fe Valencia Spain 46026

    Sponsors and Collaborators

    • Cidara Therapeutics Inc.

    Investigators

    • Study Director: Taylor Sandison, MD MPH, Cidara Therapeutics

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Cidara Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT02734862
    Other Study ID Numbers:
    • CD101.IV.2.03
    • 2015-005599-51
    First Posted:
    Apr 12, 2016
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cidara Therapeutics Inc.
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Group 1 Group 2 Group 3
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
    Period Title: Part A
    STARTED 35 36 36
    COMPLETED 23 28 22
    NOT COMPLETED 12 8 14
    Period Title: Part A
    STARTED 46 21 33
    COMPLETED 33 14 28
    NOT COMPLETED 13 7 5

    Baseline Characteristics

    Arm/Group Title Group 1 Group 2 Group 3 Total
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline Total of all reporting groups
    Overall Participants 81 57 69 207
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    49
    60.5%
    32
    56.1%
    40
    58%
    121
    58.5%
    >=65 years
    32
    39.5%
    25
    43.9%
    29
    42%
    86
    41.5%
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    59.4
    (15.86)
    60.0
    (15.90)
    59.4
    (15.85)
    59.6
    (15.79)
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    61.0
    63.0
    63.0
    62.0
    Sex: Female, Male (Count of Participants)
    Female
    37
    45.7%
    21
    36.8%
    31
    44.9%
    89
    43%
    Male
    44
    54.3%
    36
    63.2%
    38
    55.1%
    118
    57%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    8
    9.9%
    9
    15.8%
    7
    10.1%
    24
    11.6%
    Not Hispanic or Latino
    73
    90.1%
    46
    80.7%
    59
    85.5%
    178
    86%
    Unknown or Not Reported
    0
    0%
    2
    3.5%
    3
    4.3%
    5
    2.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    1
    1.8%
    3
    4.3%
    4
    1.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    8
    9.9%
    7
    12.3%
    4
    5.8%
    19
    9.2%
    White
    69
    85.2%
    44
    77.2%
    59
    85.5%
    172
    83.1%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    4
    4.9%
    5
    8.8%
    3
    4.3%
    12
    5.8%
    Region of Enrollment (participants) [Number]
    Greece
    6
    7.4%
    6
    10.5%
    8
    11.6%
    20
    9.7%
    Canada
    1
    1.2%
    1
    1.8%
    3
    4.3%
    5
    2.4%
    Romania
    2
    2.5%
    0
    0%
    3
    4.3%
    5
    2.4%
    Belgium
    9
    11.1%
    9
    15.8%
    12
    17.4%
    30
    14.5%
    Hungary
    2
    2.5%
    0
    0%
    0
    0%
    2
    1%
    United States
    26
    32.1%
    22
    38.6%
    23
    33.3%
    71
    34.3%
    Italy
    7
    8.6%
    2
    3.5%
    5
    7.2%
    14
    6.8%
    Bulgaria
    4
    4.9%
    1
    1.8%
    2
    2.9%
    7
    3.4%
    Russia
    2
    2.5%
    1
    1.8%
    0
    0%
    3
    1.4%
    Spain
    22
    27.2%
    15
    26.3%
    13
    18.8%
    50
    24.2%
    Diagnosis (Count of Participants)
    Candidemia
    62
    76.5%
    46
    80.7%
    56
    81.2%
    164
    79.2%
    Invasive Candidiasis
    19
    23.5%
    11
    19.3%
    13
    18.8%
    43
    20.8%
    Estimated Normalized Creatinine Clearance (mL/min/1.73m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mL/min/1.73m^2]
    90.8
    (52.03)
    72.8
    (52.14)
    87.1
    (59.29)
    84.9
    (54.78)
    Estimated Normalized Creatinine Clearance (mL/min/1.73m^2) [Median (Full Range) ]
    Median (Full Range) [mL/min/1.73m^2]
    81.8
    57.7
    74.4
    74.8
    Acute Physiology and Chronic Health Evaluation (APACHE) II Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    13.4
    (7.13)
    14.1
    (6.72)
    14.0
    (7.39)
    13.8
    (7.07)
    Acute Physiology and Chronic Health Evaluation (APACHE) II Score (units on a scale) [Median (Full Range) ]
    Median (Full Range) [units on a scale]
    12.0
    14.0
    13.0
    12.0
    Acute Physiology and Chronic Health Evaluation (APACHE) II Category (Count of Participants)
    0-9
    23
    28.4%
    15
    26.3%
    17
    24.6%
    55
    26.6%
    10-19
    39
    48.1%
    26
    45.6%
    37
    53.6%
    102
    49.3%
    ≥20
    17
    21%
    14
    24.6%
    9
    13%
    40
    19.3%
    Missing
    2
    2.5%
    2
    3.5%
    6
    8.7%
    10
    4.8%

    Outcome Measures

    1. Primary Outcome
    Title Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
    Description Number of Subjects with Incidence of Treatment Emergent Adverse Events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.
    Time Frame From first dose of study drug through Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.

    Outcome Measure Data

    Analysis Population Description
    Safety Population includes all subjects randomized to treatment and who received any amount of study drug. A total of 202 subjects were included in the Safety Population.
    Arm/Group Title Group 1 Group 2 Group 3
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
    Measure Participants 81 53 68
    Count of Participants [Participants]
    71
    87.7%
    49
    86%
    55
    79.7%
    2. Primary Outcome
    Title Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success]
    Description Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline
    Time Frame Day 14 (± 1 day)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1 Group 2 Group 3
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
    Measure Participants 76 46 61
    Count of Participants [Participants]
    46
    56.8%
    35
    61.4%
    41
    59.4%
    3. Secondary Outcome
    Title Mycological Eradication and Resolution of Systemic Signs
    Description Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population.
    Time Frame Day 5, and Follow-up (FU Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1 Group 2 Group 3
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
    Measure Participants 76 46 61
    Day 5
    42
    51.9%
    34
    59.6%
    34
    49.3%
    Follow-up
    36
    44.4%
    30
    52.6%
    36
    52.2%
    4. Secondary Outcome
    Title Mycological Eradication
    Description Evaluate mycological success (eradication) in the mITT population.
    Time Frame Day 5, Day 14 (±1 day), and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1 Group 2 Group 3
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
    Measure Participants 76 46 61
    Day 5
    50
    61.7%
    35
    61.4%
    38
    55.1%
    Day 14
    50
    61.7%
    35
    61.4%
    42
    60.9%
    Follow-up
    39
    48.1%
    30
    52.6%
    36
    52.2%
    5. Secondary Outcome
    Title Clinical Cure
    Description Evaluate clinical cure as assessed by the Investigator in the mITT population. Subjects must meet all of the following requirements: Resolution of attributable systemic signs and symptoms of candidemia/IC that were present at baseline No new systemic signs or symptoms attributable to candidemia/IC No additional systemic antifungal therapy administered for candidemia/IC The subject is alive
    Time Frame Day 14 (±1 day) and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1 Group 2 Group 3
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
    Measure Participants 76 46 61
    Day 14
    53
    65.4%
    37
    64.9%
    43
    62.3%
    Follow-up
    42
    51.9%
    32
    56.1%
    38
    55.1%
    6. Secondary Outcome
    Title Evaluate PK (Cmax)
    Description Evaluate maximum plasma concentration (Cmax) (Part A only)
    Time Frame Day 1, 10 minutes before end of infusion (EOI)

    Outcome Measure Data

    Analysis Population Description
    PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis.
    Arm/Group Title Group 1 Group 2
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose
    Measure Participants 29 30
    Mean (Standard Deviation) [μg/mL]
    15.258
    (5.5430)
    14.743
    (5.6450)
    7. Secondary Outcome
    Title Evaluate PK (Cmin)
    Description Evaluate minimum plasma concentration (Cmin) (Part A only)
    Time Frame Day 8, predose

    Outcome Measure Data

    Analysis Population Description
    PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis.
    Arm/Group Title Group 1 Group 2
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose
    Measure Participants 25 28
    Mean (Standard Deviation) [μg/mL]
    2.050
    (0.9767)
    2.313
    (1.2165)
    8. Secondary Outcome
    Title Evaluate PK (Cmin)
    Description Evaluate minimum plasma concentration (Cmin) (Part A only)
    Time Frame Day 15, predose

    Outcome Measure Data

    Analysis Population Description
    PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis.
    Arm/Group Title Group 1 Group 2
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose
    Measure Participants 21 21
    Mean (Standard Deviation) [μg/mL]
    3.068
    (1.4565)
    2.131
    (0.8506)

    Adverse Events

    Time Frame Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia).
    Adverse Event Reporting Description All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
    Arm/Group Title Group 1 Group 2 Group 3
    Arm/Group Description Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
    All Cause Mortality
    Group 1 Group 2 Group 3
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 14/81 (17.3%) 7/57 (12.3%) 13/69 (18.8%)
    Serious Adverse Events
    Group 1 Group 2 Group 3
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 35/81 (43.2%) 28/53 (52.8%) 29/68 (42.6%)
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Haemorrhagic anaemia 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Iron deficiency anaemia 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Sickle cell anaemia with crisis 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Cardiac disorders
    Angina pectoris 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Atrial flutter 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Atrioventricular block 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Bradycardia 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Cardiac arrest 0/81 (0%) 1/53 (1.9%) 1/68 (1.5%)
    Cardiac failure 0/81 (0%) 1/53 (1.9%) 1/68 (1.5%)
    Right ventricular failure 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Ventricular tachycardia 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Gastrointestinal disorders
    Abdominal pain 0/81 (0%) 1/53 (1.9%) 1/68 (1.5%)
    Colonic fistula 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Gastrointestinal haemorrhage 2/81 (2.5%) 1/53 (1.9%) 0/68 (0%)
    Haemorrhagic ascites 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Impaired gastric emptying 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Peritoneocutaneous fistula 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Rectal haemorrhage 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Upper gastrointestinal haemorrhage 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Vomiting 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    General disorders
    Generalised oedema 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Multiple organ dysfunction syndrome 2/81 (2.5%) 0/53 (0%) 2/68 (2.9%)
    Hepatobiliary disorders
    Biloma 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Drug-induced liver injury 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Infections and infestations
    Abdominal abscess 1/81 (1.2%) 1/53 (1.9%) 0/68 (0%)
    Abscess limb 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Bacteraemia 0/81 (0%) 2/53 (3.8%) 1/68 (1.5%)
    Bronchitis 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Candida sepsis 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Clostridium difficile colitis 2/81 (2.5%) 0/53 (0%) 0/68 (0%)
    Diverticulitis 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Endocarditis candida 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Escherichia bacteraemia 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Pelvic abscess 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Peritonitis 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Peritonitis bacterial 2/81 (2.5%) 0/53 (0%) 0/68 (0%)
    Pneumonia 2/81 (2.5%) 0/53 (0%) 1/68 (1.5%)
    Pulmonary sepsis 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Renal abscess 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Sepsis 1/81 (1.2%) 2/53 (3.8%) 2/68 (2.9%)
    Septic embolus 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Septic shock 9/81 (11.1%) 1/53 (1.9%) 2/68 (2.9%)
    Staphylococcal bacteraemia 0/81 (0%) 2/53 (3.8%) 0/68 (0%)
    Systemic candida 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Urosepsis 1/81 (1.2%) 1/53 (1.9%) 0/68 (0%)
    Injury, poisoning and procedural complications
    Fall 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Femur fracture 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Gastrointestinal stoma complication 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Post procedural fistula 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Post procedural haemorrhage 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Tracheal haemorrhage 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Vascular pseudoaneurysm 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Investigations
    Aspiration bronchial 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Metabolism and nutrition disorders
    Diabetes mellitus 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Hyperkalaemia 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Hyponatraemia 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Metabolic acidosis 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression 2/81 (2.5%) 0/53 (0%) 1/68 (1.5%)
    Malignant pleural effusion 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Neoplasm malignant 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Post transplant lymphoproliferative disorder 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Nervous system disorders
    Depressed level of consciousness 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Encephalopathy 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Metabolic encephalopathy 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Neurodegenerative disorder 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Neurological symptom 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Peroneal nerve palsy 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Seizure 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Renal and urinary disorders
    Acute kidney injury 1/81 (1.2%) 1/53 (1.9%) 0/68 (0%)
    Haematuria 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Acute respiratory failure 1/81 (1.2%) 0/53 (0%) 3/68 (4.4%)
    Apnoea 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Aspiration 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Atelectasis 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Dyspnoea 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Pleural effusion 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Pneumonia aspiration 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Pneumothorax 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Pulmonary embolism 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Respiratory arrest 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Respiratory failure 2/81 (2.5%) 1/53 (1.9%) 1/68 (1.5%)
    Skin and subcutaneous tissue disorders
    Henoch-Schonlein purpura 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Vascular disorders
    Arterial haemorrhage 0/81 (0%) 1/53 (1.9%) 0/68 (0%)
    Deep vein thrombosis 0/81 (0%) 0/53 (0%) 1/68 (1.5%)
    Shock 1/81 (1.2%) 0/53 (0%) 0/68 (0%)
    Other (Not Including Serious) Adverse Events
    Group 1 Group 2 Group 3
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 70/81 (86.4%) 49/53 (92.5%) 53/68 (77.9%)
    Blood and lymphatic system disorders
    Anaemia 6/81 (7.4%) 7/53 (13.2%) 4/68 (5.9%)
    Gastrointestinal disorders
    Diarrhoea 7/81 (8.6%) 11/53 (20.8%) 10/68 (14.7%)
    Vomiting 6/81 (7.4%) 8/53 (15.1%) 5/68 (7.4%)
    Nausea 4/81 (4.9%) 8/53 (15.1%) 6/68 (8.8%)
    Abdominal pain 5/81 (6.2%) 5/53 (9.4%) 4/68 (5.9%)
    General disorders
    Pyrexia 9/81 (11.1%) 4/53 (7.5%) 6/68 (8.8%)
    Oedema peripheral 6/81 (7.4%) 2/53 (3.8%) 0/68 (0%)
    Metabolism and nutrition disorders
    Hypokalaemia 13/81 (16%) 9/53 (17%) 9/68 (13.2%)
    Psychiatric disorders
    Insomnia 4/81 (4.9%) 4/53 (7.5%) 2/68 (2.9%)
    Skin and subcutaneous tissue disorders
    Decubitus ulcer 4/81 (4.9%) 3/53 (5.7%) 3/68 (4.4%)
    Vascular disorders
    Hypotension 6/81 (7.4%) 2/53 (3.8%) 4/68 (5.9%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Results Point of Contact

    Name/Title Taylor Sandison, M.D., MPH
    Organization Cidara Therapeutics, Inc.
    Phone 858-888-7868
    Email clinicaltrialinfo@cidara.com
    Responsible Party:
    Cidara Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT02734862
    Other Study ID Numbers:
    • CD101.IV.2.03
    • 2015-005599-51
    First Posted:
    Apr 12, 2016
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Dec 1, 2020