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NCT04368559 · ClinicalTrials.gov registry record · Phase 3
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 study of Candidemia and Mycoses, sponsored by Mundipharma Research Limited.
- Active
- Registry status
- Phase 3
- Development phase
- 602
- Enrollment target
- 20
- Study locations
NCT04368559: Active Phase 3 study of Candidemia and Mycoses, sponsored by Mundipharma Research Limited.
NCT04368559 is a Phase 3 study of Candidemia and Mycoses that is active but no longer recruiting, run by Mundipharma Research Limited. The registered enrollment target is 602 participants, above the 339-participant average among 8 other Candidemia trials with a reported enrollment target (78% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04368559, a Phase 3 study of Candidemia and Mycoses, is active but no longer recruiting, sponsored by Mundipharma Research Limited.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 602 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The number of subjects in each treatment group who are fungal-free and survive.
Conditions Studied
Interventions
- DRUG Fluconazole
- DRUG Posaconazole
- DRUG Intravenous Placebo
- DRUG Rezafungin for Injection
- DRUG Trimethoprim-sulfamethoxazole (TMP/SMX)
Study Locations (20)
California
- UCLA Center for Health Sciences - Los Angeles
- Stanford University School of Medicine - Stanford
Illinois
- Rush University Medical Center - Chicago
- University of Chicago - Chicago
Maryland
- University of Maryland Medical Center - Baltimore
- John Hopkins - Baltimore
Minnesota
- University of Minnesota Physicians - Minneapolis
- Mayo Clinic - Rochester
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Augusta University Medical Center - Augusta
Massachusetts
- Massachusetts General Hospital - Boston
New Hampshire
- Mary Hitchcock Memorial Hospital Dartmouth-Hitchcock - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2020-05-11 |
| Est. Completion | 2026-02 |
| Phase | Phase 3 |
What the registry record for NCT04368559 still lists
NCT04368559 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, above the 339-participant average among 8 other Candidemia trials with a reported enrollment target (78% higher).
The record links to 10 conditions, with Candidemia appearing as the primary indexed condition, and to 5 interventions - of which Fluconazole is the first listed.
NCT04368559 names 20 study sites across 16 states, led by California, Illinois, Maryland.
Frequently Asked Questions
What is clinical trial NCT04368559 about?
NCT04368559 is a clinical study titled "Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation". 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.
What is the current status of trial NCT04368559?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 602 participants. The study started on 2020-05-11. Estimated completion is 2026-02.
What conditions does trial NCT04368559 study?
This clinical trial studies the following conditions: Candidemia, Mycoses, Fungal Infection, Invasive Candidiasis, Fungemia.
What interventions are being tested in trial NCT04368559?
The interventions under investigation include: Fluconazole (DRUG), Posaconazole (DRUG), Intravenous Placebo (DRUG), Rezafungin for Injection (DRUG), Trimethoprim-sulfamethoxazole (TMP/SMX) (DRUG).
Who is sponsoring clinical trial NCT04368559?
This trial is sponsored by Mundipharma Research Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04368559 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Candidemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04368559's enrollment target sits among peer trials
602 3rd of 8 higher than 6 of 8 other Candidemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Candidemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
RECRUITING · Phase 3
-
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
COMPLETED · Phase 3
-
Study of Micafungin in Patients With Invasive Candidiasis or Candidemia
COMPLETED · Phase 3
-
Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemia
RECRUITING · Phase 2
-
Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
COMPLETED · Phase 1
-
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)
COMPLETED
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