Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

Details

A Phase 3, multicenter, prospective, randomized, double-blind, efficacy and safety study of Rezafungin for Injection versus an active comparator regimen of caspofungin followed by optional oral fluconazole step-down therapy in subjects with candidemia and/or invasive candidiasis.

Keywords

Candidemia Mycoses Fungal Infection Invasive Candidiases Candidiasis Candidiasis, Invasive Fungemia Sepsis Invasive Fungal Infections Systemic Inflammatory Response Syndrome 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 Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Rezafungin for Injection

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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 his/her behalf.
  2. Males or females ≥18 years of age.
  3. Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken ≤4 days (96 hours) before randomization defined as
  4. ≥1 blood culture positive for yeast or Candida OR
  5. Positive test for Candida from a Sponsor-approved rapid IVD OR
  6. Positive gram stain (or other method of direct microscopy) for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site.
  7. Presence of one or more systemic signs attributable to candidemia or invasive candidiasis appearing from ≤12 hours prior to the qualifying positive culture through time of enrollment.
  8. Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
  9. Female subjects of childbearing potential <2 years post-menopausal must agree to and comply with using one barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control, or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception, and also agree not to donate sperm while participating in the study and for 90 days thereafter.

You CAN'T join if...

  1. Any of the following forms of invasive candidiasis at baseline:
  2. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
  3. Osteomyelitis
  4. Endocarditis or myocarditis
  5. Meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection
  6. Chronic disseminated candidiasis
  7. Urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract
  8. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for >48 hours (e.g., >2 doses of a once daily antifungal agent or >4 doses of a twice daily antifungal agent) ≤4 days (96 hours) before randomization
  9. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible
  10. Alanine aminotransferase or aspartate aminotransferase levels >10-fold the upper limit of normal
  11. Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score >9)
  12. Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or invasive candidiasis
  13. Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients
  14. Meets National Cancer Institute Common Terminology Criteria for Adverse Events, version 5, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher
  15. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's Disease or Huntington's Disease)
  16. Planned or ongoing therapy at Screening with a known neurotoxic medication
  17. . Previous participation in this or any previous rezafungin study
  18. . Current participation in another interventional treatment trial with an investigational agent
  19. . Recent use of an investigational medicinal product within 28 days of the first dose of study drug or presence of an investigational device at the time of screening.
  20. . Pregnant or lactating females
  21. . The Principal Investigator (PI) is of the opinion the subject should not participate in the study
  22. . Severe renal impairment during Screening (Creatinine Clearance < 30 mL/min by Cockcroft-Gaul) including patients on hemodialysis or chronic renal replacement therapy.

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • Mecury Street Medical accepting new patients
    Butte Montana 59701 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cidara Therapeutics Inc.
Links
Sign up for this study
ID
NCT03667690
Phase
Phase 3
Study Type
Interventional
Last Updated