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

NCT04368559 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Mundipharma Research Limited

    lead INDUSTRY

Principal Investigators

  • Laura Cox, PhD · Mundipharma Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-11
Primary Completion
2026-01-29
Completion
2026-01-29
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

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 NCT04368559 on ClinicalTrials.gov