JPRN-jRCT2031230313招募中3 期
A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome (R) followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species
Gomez Juan Carlos0 个研究点目标入组 225 人开始时间: 2023年8月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Male and female patients ages>=18 years and weighing >= 30 kg
- •2.Patients with proven invasive aspergillosis (IA) at any site or probable lower respiratory tract disease Aspergillus species (LRTD IA).
- •3.Patients requiring therapy with an antifungal agent other than a mould-active azole.
- •4.AmBisome (R) is an appropriate therapy for the patient.
排除标准
- •1.Women who are pregnant or breastfeeding.
- •2.Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug (olorofim or AmBisome (R) ).
- •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.
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the efficacy and safety of olorofim versus AmBisome® for treatment of invasive aspergillosis.EUCTR2021-000386-32-NLF2G Ltd.225
进行中（未招募）
1 期
A study to evaluate the efficacy and safety of olorofim versus AmBisome® for treatment of invasive aspergillosis.invasive fungal infections due to Aspergillus spp.MedDRA version: 20.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-000386-32-FRF2G Ltd.225
进行中（未招募）
1 期
A study to evaluate the efficacy and safety of olorofim versus AmBisome® for treatment of invasive aspergillosis.invasive fungal infections due to Aspergillus spp.MedDRA version: 20.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-000386-32-BEF2G Ltd.225
招募中
1 期
A study to evaluate the efficacy and safety of olorofim versus AmBisome® for treatment of invasive aspergillosisInvasive fungal infections due to Aspergillus spp.MedDRA version: 20.0Level: PTClassification code: 10017533Term: Fungal infection Class: 100000004862CTIS2024-513030-38-00F2G Limited225
尚未招募
3 期
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 speciesfungal infections on other places than skin or mucous membranesinvasive fungal infections due to Aspergillus species10017528NL-OMON56006F2G Ltd.10