At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 199 enrolled
Drug / intervention
Rezafungin for Injection +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Sep 12, 2018·Updated Jan 6, 2023
In Brief
A Phase 3 clinical trial evaluating Rezafungin for Injection, Caspofungin, and 3 other interventions for Candidemia and 3 related conditions. Completed, enrolled 199 participants across 132 sites in 18 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCandidemia, Mycoses, Fungal Infection, Invasive Candidiases
CountriesArgentina, Australia, Belgium, Bulgaria, China, Colombia, France, Germany, Greece, Israel, Italy, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartOct 2018
Primary CompletionOct 2021
TodayJul 2026
First PostedSep 12, 2018
Enrollment StartOct 7, 2018
Primary CompletionOct 7, 2021
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 7.8 years ago
Interventions
Rezafungin for Injectiondrug
Intravenous antifungal therapy
Caspofungindrug
Intravenous antifungal therapy
Fluconazoledrug
Oral antifungal therapy
intravenous placebodrug
Normal saline
oral placebodrug
Microcrystalline cellulose