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

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ClinicalTrials.gov Identifier: NCT02734862
Recruitment Status : Recruiting
First Posted : April 12, 2016
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Cidara Therapeutics Inc.

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
Candidemia Mycoses Fungal Infection Fungemia Invasive Candidiasis Drug: CD101 Drug: Caspofungin Drug: Fluconazole Drug: intravenous placebo Drug: oral placebo 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 227 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 : July 26, 2016
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2018


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 Name: CD101 for Injection

Drug: intravenous placebo
normal saline
Other Name: placebo infusion

Drug: oral placebo
microcrystalline cellulose
Other Name: 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 Name: Cancidas

Drug: Fluconazole
oral antifungal therapy
Other Name: generic fluconazole

Drug: intravenous placebo
normal saline
Other Name: 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 Name: CD101 for Injection

Drug: intravenous placebo
normal saline
Other Name: placebo infusion

Drug: oral placebo
microcrystalline cellulose
Other Name: encapsulated cellulose




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events [Safety and Tolerability] [ Time Frame: 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. Mycological eradication or presumed mycological eradication [Overall Success] [ Time Frame: Day 14 (± 1 day) ]
    Number of subjects with negative blood culture(s) for yeast or Candida and no change of antifungal therapy for treatment of candidemia or number of subjects in whom no follow-up culture is available with no change of antifungal treatment for invasive candidiasis and resolution of or improvement of any baseline radiographic abnormalities due to invasive candidiasis

  3. Resolution of systemic signs attributable to candidemia and/or invasive candidiasis [Overall Success] [ Time Frame: Day 14 (± 1 day) ]
    Number of subjects with 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 [ Time Frame: Day 5, Day 28 (± 2 days; only for subjects with IC); 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 [ Time Frame: Day 5, Day 14 (±1 day), Day 28 (±2 days; only for subjects with IC); 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 [ Time Frame: Day 14 (±1 day), Day 28 (±2 days; only for subjects with IC), 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.

  4. Evaluate PK (Cmax) [ Time Frame: Days 1, 2, 4, 8 and 15. ]
    Evaluate maximum plasma concentration (Cmax) (Part A only)

  5. Evaluate PK (time to Cmax) [ Time Frame: Days 1, 2, 4, 8 and 15. ]
    Evaluate time to Cmax (Part A only)

  6. Evaluate PK (AUC) [ Time Frame: Days 1, 2, 4, 8 and 15. ]
    Evaluate area under the curve (AUC) (Part A only)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734862


Contacts
Contact: Karen Mena (858) 888-7868 clinicaltrialinfo@cidara.com

  Show 61 Study Locations
Sponsors and Collaborators
Cidara Therapeutics Inc.
Investigators
Study Director: Taylor Sandison, MD MPH Cidara Therapeutics

Responsible Party: Cidara Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02734862     History of Changes
Other Study ID Numbers: CD101.IV.2.03
2015-005599-51 ( EudraCT Number )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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.:
mycoses

Additional relevant MeSH terms:
Mycoses
Candidiasis
Candidemia
Candidiasis, Invasive
Fungemia
Sepsis
Infection
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors