NCT04368559

Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation

A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Mundipharma Research Limited · 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 prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.

Detailed description

A Phase 3, multicenter, prospective, randomized, double-blind, efficacy and safety study of Rezafungin for injection versus the standard antimicrobial regimen for the prevention of invasive fungal diseases in subjects undergoing allogeneic blood and marrow transplantation.

Conditions

• Candidemia
• Mycoses
• Fungal Infection
• Fungemia
• Invasive Candidiasis
• Pneumocystis
• Mold Infection
• Invasive Fungal Disease
• Prophylaxis of Invasive Fungal Infections
• Aspergillus

Interventions

Type	Name	Description
DRUG	Rezafungin for Injection	Intravenous antifungal therapy
DRUG	Posaconazole	Oral antifungal therapy
DRUG	Fluconazole	Oral antifungal therapy
DRUG	Trimethoprim-sulfamethoxazole (TMP/SMX)	Oral antibacterial therapy
DRUG	Intravenous Placebo	Normal saline
DRUG	Oral Placebo	Microcrystalline cellulose

Timeline

• Start date: 2020-05-11
• Primary completion: 2026-01-29
• Completion: 2026-01-29
• First posted: 2020-04-30
• Last updated: 2026-04-13

Locations

53 sites across 9 countries: United States, Belgium, Canada, France, Germany, Italy, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study