Olorofim Aspergillus Infection Study

Running, not enrolling · Phase 3

Conditions studied: Invasive Aspergillosis

In brief

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).

Key facts

Study ID

NCT05101187

Run by

F2G Biotech GmbH

People needed

225

Starts

2022-03-31

Expected to finish

2026-11-01

Last updated by the study team

2026-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients ages over 18 years and weighing more than 30 kg
• Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study and where the duration of specific therapy for this episode of IA has been ≤ 28 days. For purposes of this inclusion, the duration of specific therapy includes any mould-active therapy given for this episode of IA whether subsequently judged potentially effective or not.
• Patients requiring therapy with an antifungal agent other than a mould-active azole, and who have had ≤ 96 hours of potentially effective prior therapy. Potentially effective prior therapy includes any agent to which the infecting strain of Aspergillus is likely to be susceptible. There are no exclusions or limitations on such agents (eg, AmBisome® is permitted) other than their duration.
• AmBisome® is an appropriate therapy for the patient.

You may not qualify if…

• Women who are pregnant or breastfeeding.
• Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
• Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
• Suspected mucormycosis (zygomycosis).
• Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole.
• The requirement for ongoing use of echinocandin as Candida prophylaxis.
• Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features.
• Human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy.
• Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation.
• Evidence of hepatic dysfunction.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• University of California Davis Health System — Sacramento, California, United States
• UCSF Helen Diller Medical Center at Parnassus Heights — San Francisco, California, United States
• University of Florida — Gainesville, Florida, United States
• Augusta University — Augusta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• NIH Clinical Center ,NIAID,NIH — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Clairvoyant Research Group, LLC — Las Vegas, Nevada, United States
• Rutgers RWJMS — New Brunswick, New Jersey, United States
• Weill Cornell Medicine NY Presbyterian Hospital — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke Department of Medicine Infectious Diseases Division — Durham, North Carolina, United States
• OU Health OU Medical Center — Oklahoma City, Oklahoma, United States
• University of Pittsburgh Medical Center Health System — Pittsburgh, Pennsylvania, United States
• Houston Methodist — Houston, Texas, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Royal NorthShore Hospital — Saint Leonards, New South Wales, Australia
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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