NCT02734862

CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (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 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).

Detailed description

This Bridging Extension is to determine if intravenous CD101 is safe \[Day 45- 52 for subjects with candidemia only, or Day 52- 59 for subjects with invasive candidiasis with or without candidemia\] and effective \[Day 14 (± 1 day)\] 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

Type	Name	Description
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

Timeline

• Start date: 2016-07-26
• Primary completion: 2019-06-01
• Completion: 2019-07-01
• First posted: 2016-04-12
• Last updated: 2020-12-08
• Results posted: 2020-12-08

Locations

63 sites across 10 countries: United States, Belgium, Bulgaria, Canada, Greece, Hungary, Italy, Romania, Russia, Spain

Regulatory

• FDA-regulated drug study