🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT05101187
Active, not recruiting Phase 3

Olorofim Aspergillus Infection Study

NCT05101187 · tracked via the Priya Life Science UK tracker
Sponsor
F2G Biotech GmbH
Phase
Phase 3
Started
2022-03-31
Last updated
2026-01-06

Condition(s) studied

Invasive Aspergillosis

Investigational drug(s) / intervention(s)

OlorofimAmBisome®

Olorofim: Loading Dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 Maintenance Dose: 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 84 (± 7 days)

AmBisome®: Initial course of at least 10 days of AmBisome® administered daily at a dose of 3 mg/kg by IV infusion over a 30- to 60-minute period or according to local guidelines Administration of SOC will follow international, national, or local guidelines and product labelling.

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion 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. Exclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (140)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
City of Hope National Medical Center Duarte California
University of California Davis Health System Sacramento California
UCSF Helen Diller Medical Center at Parnassus Heights San Francisco California
University of Florida Gainesville Florida
Augusta University Augusta Georgia
University of Chicago Medical Center Chicago Illinois
University of Kansas Medical Center Kansas City Kansas
The Johns Hopkins Hospital Baltimore Maryland
NIH Clinical Center ,NIAID,NIH Bethesda Maryland
Massachusetts General Hospital Boston Massachusetts
University of Michigan Ann Arbor Michigan
University of Minnesota Minneapolis Minnesota
Mayo Clinic - Rochester Rochester Minnesota
Washington University School of Medicine St Louis Missouri
Clairvoyant Research Group, LLC Las Vegas Nevada
Rutgers RWJMS New Brunswick New Jersey
Weill Cornell Medicine NY Presbyterian Hospital New York New York
University of North Carolina at Chapel Hill Chapel Hill North Carolina
Duke Department of Medicine Infectious Diseases Division Durham North Carolina
OU Health OU Medical Center Oklahoma City Oklahoma
University of Pittsburgh Medical Center Health System Pittsburgh Pennsylvania
Houston Methodist Houston Texas
Fred Hutchinson Cancer Center Seattle Washington
Royal NorthShore Hospital Saint Leonards New South Wales
Royal Brisbane & Women's Hospital Herston Queensland
The Alfred Hospital Melbourne Victoria
Royal Melbourne Hospital Parkville Victoria
Fiona Stanley Hospital Murdoch Western Australia
AZ Sint-Jan Bruges Belgium
Hôpital Erasme Brussels Belgium
Universitair Ziekenhuis Gent Ghent Belgium
UZ Leuven Leuven Belgium
Hospital Felício Rocho Belo Horizonte Minas Gerais
Santa Casa de Misericórdia de Belo Horizonte Belo Horizonte Minas Gerais
Santa Casa de Misericórdia de Passos Passos Minas Gerais
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer Curitiba Paraná
Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre Rio Grande do Sul
Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande do Sul
Hospital São Lucas da PUCRS Porto Alegre Rio Grande do Sul

+ 100 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05101187 on ClinicalTrials.gov ↗ ← All trials in the UK