CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
NCT02734862 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207
Last updated 2020-12-08
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).
Conditions
- Candidemia
- Mycoses
- Fungal Infection
- Fungemia
- Invasive Candidiasis
Interventions
- DRUG
-
CD101
Intravenous antifungal therapy
- DRUG
-
Caspofungin
Intravenous antifungal therapy
- DRUG
-
Fluconazole
oral antifungal therapy
- DRUG
-
intravenous placebo
normal saline
- DRUG
-
oral placebo
microcrystalline cellulose
Sponsors & Collaborators
-
Cidara Therapeutics Inc.
lead INDUSTRY
Principal Investigators
-
Taylor Sandison, MD MPH · Cidara Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-26
- Primary Completion
- 2019-06-30
- Completion
- 2019-07-31
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Bulgaria
- Canada
- Greece
- Hungary
- Italy
- Romania
- Russia
- Spain
Study Locations
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