NCT03667690

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Candidemia
• Mycoses
• Fungal Infection
• Invasive Candidiases

Interventions

Type	Name	Description
DRUG	Rezafungin for Injection	Intravenous antifungal therapy
DRUG	Caspofungin	Intravenous antifungal therapy
DRUG	Fluconazole	Oral antifungal therapy
DRUG	intravenous placebo	Normal saline
DRUG	oral placebo	Microcrystalline cellulose

Timeline

• Start date: 2018-10-07
• Primary completion: 2021-10-07
• Completion: 2021-10-07
• First posted: 2018-09-12
• Last updated: 2023-01-06
• Results posted: 2023-01-06

Locations

132 sites across 18 countries: United States, Argentina, Australia, Belgium, Bulgaria, China, Colombia, France, Germany, Greece, Israel, Italy, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study