ACTIVE_NOT_RECRUITING

Olorofim Aspergillus Infection Study

Conditions

Invasive Aspergillosis Invasive fungal disease (IFD)Aspergillus species Olorofim Non-azole antifungal Azole resistance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-03-31

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05101187

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Johan Maertens, MD

PRINCIPAL_INVESTIGATOR

UZ Leuven

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35249

United States

City of Hope National Medical Center

Duarte, California, 91010

United States

University of California Davis Health System

Sacramento, California, 95817

United States

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, 94143

United States

University of Florida

Gainesville, Florida, 32610

United States

Augusta University

Augusta, Georgia, 30912

United States

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

University of Kansas Medical Center

Kansas City, Kansas, 64111

United States

The Johns Hopkins Hospital

Baltimore, Maryland, 21287

United States

NIH Clinical Center ,NIAID,NIH

Bethesda, Maryland, 20892

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

United States

Washington University School of Medicine

St Louis, Missouri, 63110

United States

Clairvoyant Research Group, LLC

Las Vegas, Nevada, 89119

United States

Rutgers RWJMS

New Brunswick, New Jersey, 08901

United States

Weill Cornell Medicine NY Presbyterian Hospital

New York, New York, 10065

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514

United States

Duke Department of Medicine Infectious Diseases Division

Durham, North Carolina, 27710

United States

OU Health OU Medical Center

Oklahoma City, Oklahoma, 73104

United States

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, 15232

United States

Houston Methodist

Houston, Texas, 77030

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109-1024

United States

Collaborators and Investigators

Sponsor: F2G Biotech GmbH

Johan Maertens, MD, PRINCIPAL_INVESTIGATOR, UZ Leuven

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-31

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2022-03-31

Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

Invasive fungal disease (IFD)
Aspergillus species
Olorofim
Non-azole antifungal
Azole resistance

Additional Relevant MeSH Terms

Invasive Aspergillosis