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ACTIVE NOT RECRUITING Phase 3

Olorofim Aspergillus Infection Study

NCT05101187 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

Conditions Studied

Interventions

  • DRUG Olorofim
  • DRUG AmBisome®

Study Locations (20)

California

  • City of Hope National Medical Center — Duarte
  • University of California Davis Health System — Sacramento
  • UCSF Helen Diller Medical Center at Parnassus Heights — San Francisco

Maryland

  • The Johns Hopkins Hospital — Baltimore
  • NIH Clinical Center ,NIAID,NIH — Bethesda

Minnesota

  • University of Minnesota — Minneapolis
  • Mayo Clinic - Rochester — Rochester

North Carolina

  • University of North Carolina at Chapel Hill — Chapel Hill
  • Duke Department of Medicine Infectious Diseases Division — Durham

Alabama

  • University of Alabama at Birmingham — Birmingham

Florida

  • University of Florida — Gainesville

Georgia

  • Augusta University — Augusta

Illinois

  • University of Chicago Medical Center — Chicago

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2022-03-31
Est. Completion 2026-11-01
Phase Phase 3

Sponsor

F2G Biotech

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05101187

The ClinicalTrials.gov registry entry for NCT05101187 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 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is F2G Biotech, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Invasive Aspergillosis appearing as the primary indexed condition, and to 2 interventions — of which Olorofim 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: NCT05101187 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Maryland, Minnesota. 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 NCT05101187 about?

NCT05101187 is a clinical study titled "Olorofim Aspergillus Infection Study". The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

What is the current status of trial NCT05101187?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2022-03-31. Estimated completion is 2026-11-01.

What conditions does trial NCT05101187 study?

This clinical trial studies the following conditions: Invasive Aspergillosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05101187?

The interventions under investigation include: Olorofim (DRUG), AmBisome® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05101187?

This trial is sponsored by F2G Biotech, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05101187 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. 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