At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 207 enrolled
Drug / intervention
CD101 +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 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
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Apr 12, 2016·Updated Dec 8, 2020
In Brief
A Phase 2 clinical trial evaluating CD101, Caspofungin, and 3 other interventions for Candidemia and 4 related conditions. Completed, enrolled 207 participants across 63 sites in 10 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCandidemia, Mycoses, Fungal Infection, Fungemia, Invasive Candidiasis
CountriesBelgium, Bulgaria, Canada, Greece, Hungary, Italy, Romania, Russia, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJul 2016
Primary CompletionJun 2019
Study CompletionJul 2019
TodayJul 2026
First PostedApr 12, 2016
Enrollment StartJul 26, 2016
Primary CompletionJun 1, 2019
Study CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.2 years ago
Interventions
CD101drug
Intravenous antifungal therapy
Caspofungindrug
Intravenous antifungal therapy
Fluconazoledrug
oral antifungal therapy
intravenous placebodrug
normal saline
oral placebodrug
microcrystalline cellulose