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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
NCT05421858 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida. The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis. Two-thirds of all patients will receive the study medication fosmanogepix Intravenous (IV) infusion followed by optional fosmanogepix tablets. One-third of all patients will receive a standard of care regimen of caspofungin Intravenous (IV) infusion followed by optional fluconazole capsules. Fosmanogepix or caspofungin will first be given as an Intravenous (IV) infusion directly into a vein in the arm each day at the study clinic. Fosmanogepix tablets or fluconazole capsules will be taken orally by mouth daily either at the study clinic, or at home if patients are well enough to be discharged from the hospital. The treatment effect in patients receiving fosmanogepix to those receiving caspofungin/ fluconazole will be compared. The primary aim is to show that fosmanogepix is not inferior (not worse) to caspofungin/ fluconazole with a noninferiority margin of 15%. The duration of study treatment and number of study visits will vary depending on how long the patient will be treated for the infection. Treatment will continue for a maximum of 6 weeks depending on when the infection is cleared and whether other symptoms related to the infection have improved. There will also be a follow-up visit 6 weeks after the study treatment was stopped.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fluconazole
- DRUG Fosmanogepix
- DRUG Caspofungin
Study Locations (20)
California
- City of Hope — Duarte
- David Geffen School of Medicine at UCLA — Los Angeles
- UC Davis Medical Center — Sacramento
Michigan
- University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center — Ann Arbor
- DMC Harper University Hospital — Detroit
- Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases — Detroit
Georgia
- Emory University Hospital - Clifton Road — Atlanta
- Augusta University Medical Center — Augusta
Pennsylvania
- University of Pennsylvania School of Medicine — Philadelphia
- UPMC Presbyterian — Pittsburgh
Texas
- Houston Methodist Hospital - Texas Medical Center — Houston
- The University of Texas Health Science Center at Houston — Houston
Alabama
- University of Alabama at Birmingham School of Medicine, Department of Medicine — Birmingham
Indiana
- Indiana University Methodist Hospital — Indianapolis
Kentucky
- University of Kentucky College of Medicine — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-12-11 |
| Est. Completion | 2028-01-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05421858
The ClinicalTrials.gov registry entry for NCT05421858 describes a study currently listed as 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 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Basilea Pharmaceutica, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Candidemia appearing as the primary indexed condition, and to 4 interventions — of which Placebo 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: NCT05421858 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Michigan, Georgia. 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 NCT05421858 about?
NCT05421858 is a clinical study titled "A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.". The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida. The study is seeking ...
What is the current status of trial NCT05421858?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2024-12-11. Estimated completion is 2028-01-30.
What conditions does trial NCT05421858 study?
This clinical trial studies the following conditions: Candidemia, Candidiasis, Invasive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05421858?
The interventions under investigation include: Placebo (DRUG), Fluconazole (DRUG), Fosmanogepix (DRUG), Caspofungin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05421858?
This trial is sponsored by Basilea Pharmaceutica, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05421858 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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