Olorofim Aspergillus Infection Study

Description

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

Invasive Aspergillosis

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Study Overview

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Study Details

Study overview

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).

Phase III, Adjudicator-blinded, Randomised Study to Evaluate Efficacy and Safety of Treatment With Olorofim Versus Treatment With AmBisome® Followed by Standard of Care in Patients With Invasive Fungal Disease Caused by Aspergillus Species

Olorofim Aspergillus Infection Study

Condition
Invasive Aspergillosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35249

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Sacramento

University of California Davis Health System, Sacramento, California, United States, 95817

San Francisco

UCSF Helen Diller Medical Center at Parnassus Heights, San Francisco, California, United States, 94143

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Augusta

Augusta University, Augusta, Georgia, United States, 30912

Chicago

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 64111

Baltimore

The Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Bethesda

NIH Clinical Center ,NIAID,NIH, Bethesda, Maryland, United States, 20892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male and female patients ages over 18 years and weighing more than 30 kg
  • 2. 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.
  • 3. 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.
  • 4. AmBisome® is an appropriate therapy for the patient.
  • 1. Women who are pregnant or breastfeeding.
  • 2. Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug
  • 3. Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
  • 4. Suspected mucormycosis (zygomycosis).
  • 5. Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole.
  • 6. The requirement for ongoing use of echinocandin as Candida prophylaxis.
  • 7. Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features.
  • 8. Human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy.
  • 9. Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation.
  • 10. Evidence of hepatic dysfunction.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

F2G Biotech GmbH,

Johan Maertens, MD, PRINCIPAL_INVESTIGATOR, UZ Leuven

Study Record Dates

2026-11-01