Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
F2G Biotech GmbH (Voir sur ClinicalTrials)
mars 2022
novembre 2026
02 février 2026
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).
Etablissements
| Etablissement | Contact | Statut | Actualisé | ||
|---|---|---|---|---|---|
| Etablissement non spécifié, référez vous à la page NCT pour plus d'information Origine et niveau de fiabilité des données | |||||
Critères
Tous
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.