Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02734862
Recruitment Status : Completed
First Posted : April 12, 2016
Results First Posted : December 8, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Cidara Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE March 16, 2016
First Posted Date  ICMJE April 12, 2016
Results First Submitted Date  ICMJE September 4, 2020
Results First Posted Date  ICMJE December 8, 2020
Last Update Posted Date December 8, 2020
Actual Study Start Date  ICMJE July 26, 2016
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] [ 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. ]
    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.
  • Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Day 28 - 35 ]
    Adverse events, clinical chemistry and hematology laboratory tests, vital signs, physical exams
  • Negative blood culture [ Time Frame: Day 14 ]
    Negative blood culture(s) for yeast [mycological eradication]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • Mycological Eradication and Resolution of Systemic Signs [ 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. ]
    Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population.
  • Mycological Eradication [ 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) ]
    Evaluate mycological success (eradication) in the mITT population.
  • Clinical Cure [ 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). ]
    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
  • Evaluate PK (Cmax) [ Time Frame: Day 1, 10 minutes before end of infusion (EOI) ]
    Evaluate maximum plasma concentration (Cmax) (Part A only)
  • Evaluate PK (Cmin) [ Time Frame: Day 8, predose ]
    Evaluate minimum plasma concentration (Cmin) (Part A only)
  • Evaluate PK (Cmin) [ Time Frame: Day 15, predose ]
    Evaluate minimum plasma concentration (Cmin) (Part A only)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • Negative blood culture [ Time Frame: Day 5 ]
    Negative blood culture(s) for yeast [mycological eradication]
  • Resolution of clinical signs and symptoms of candidemia [ Time Frame: Day 14 ]
    Complete resolution of most or all the clinical signs and symptoms of candidemia which were present at baseline AND no new signs/ symptoms or complications attributable to candidemia AND no additional antifungal therapy administered for candidemia AND the subject is alive [clinical cure]
  • Resolution of clinical signs and symptoms of candidemia [ Time Frame: Day 28 - 35 ]
    Complete resolution of most or all the clinical signs and symptoms of candidemia which were present at baseline AND no new signs/ symptoms or complications attributable to candidemia AND no additional antifungal therapy administered for candidemia AND the subject is alive [clinical cure]
  • Negative blood culture [ Time Frame: Day 28 - 35 ]
    Negative blood culture(s) for yeast [mycological eradication]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
Official Title  ICMJE 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
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Candidemia
  • Mycoses
  • Fungal Infection
  • Fungemia
  • Invasive Candidiasis
Intervention  ICMJE
  • Drug: CD101
    Intravenous antifungal therapy
    Other Name: CD101 for Injection
  • Drug: Caspofungin
    Intravenous antifungal therapy
    Other Name: Cancidas
  • Drug: Fluconazole
    oral antifungal therapy
    Other Name: generic fluconazole
  • Drug: intravenous placebo
    normal saline
    Other Name: placebo infusion
  • Drug: oral placebo
    microcrystalline cellulose
    Other Name: encapsulated cellulose
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: CD101
    • Drug: intravenous placebo
    • Drug: oral placebo
  • 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.

    Interventions:
    • Drug: Caspofungin
    • Drug: Fluconazole
    • Drug: intravenous placebo
  • 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.

    Interventions:
    • Drug: CD101
    • Drug: intravenous placebo
    • Drug: oral placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2020)
207
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2016)
90
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Canada,   Greece,   Hungary,   Italy,   Romania,   Russian Federation,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02734862
Other Study ID Numbers  ICMJE CD101.IV.2.03
2015-005599-51 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cidara Therapeutics Inc.
Study Sponsor  ICMJE Cidara Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Taylor Sandison, MD MPH Cidara Therapeutics
PRS Account Cidara Therapeutics Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP