jRCT2031230313招募中不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 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.
结局指标
主要结局
-
All cause mortality at Day 42 in the intent-to-treat (ITT) population
次要结局
未报告次要终点
研究者
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