A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species.

F2G Ltd.0 个研究点目标入组 225 人开始时间: 2021年9月29日最近更新: 2023年9月26日

研究概览

暂无简介。

•1) Male and female patients ages =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.
•5) Ability and willingness to comply with the protocol.
•6) Female patients must be non-lactating and at no risk of pregnancy.
•7) Male patients with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception
•8) Patients must be able to take oral medication.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 169
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 56

•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.

发起方