CompletedPhase 3

Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis

United States199 participantsStarted 2018-10-07

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Males or females ≥18 years of age.
✓. Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken ≤4 days (96 hours) before randomization defined as
✓. 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 randomization.
✓. Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
✓. Female subjects of childbearing potential (all female subjects between 18 years \<2 years post-menopausal unless surgically sterile) 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 (and at least 120 days from the last dose of study drug).
✓. For Candidemia only subjects, drawing of a set of blood cultures within 12 hours prior to randomization in the study. The result of these blood cultures is not required for inclusion in the study.

Exclusion criteria

✕. Any of the following forms of invasive candidiasis at baseline:

What they're measuring

All-Cause Mortality (US FDA Only)

Timeframe: Day 30 (-2 days)

Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only)

Timeframe: Day 14 (±1 day)

Trial details

NCT IDNCT03667690

SponsorCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-07

Results submitted2022-10-07

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