Olorofim Aspergillus Infection Study

• Status: Not yet recruiting
• Trial end date: 2025-03-04
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: F2G Biotech GmbH
• Collaborator: Iqvia Pty Ltd
• Treatments: Amphotericin B; Liposomal amphotericin B; Olorofim

Criteria

Inclusion Criteria:

1. Male and female patients ages over 18 years and weighing more than 40 kg

2. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study

3. Patients requiring therapy with an antifungal agent other than a mould-active azole on the basis of IA refractory to mould-active azole therapy, proven resistance to the mould active azoles, breakthrough infection on mould-active triazole prophylaxis, or azole drug-drug interactions (or potential for drug-drug interactions).

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 use of an 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.