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ACTIVE NOT RECRUITING Phase 3

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

NCT04368559 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 602 participants
Start Date 2020-05-11
Est. Completion 2026-02
Phase Phase 3

Sponsor

Mundipharma Research Limited

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04368559

The ClinicalTrials.gov registry entry for NCT04368559 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 602 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mundipharma Research Limited, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04368559 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Illinois, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04368559?

This trial is sponsored by Mundipharma Research Limited, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial