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

NCT03667690 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2023-01-06

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Cidara Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Taylor Sandison, MD, MPH · Cidara Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-07
Primary Completion
2021-10-07
Completion
2021-10-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • China
  • Colombia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03667690 on ClinicalTrials.gov