Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Cure rate (CR) of emodepside against Trichuris trichiura
研究概览
简要总结
The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults aged between 18 and 45 years
- •Written and signed informed consent
- •Examined by a study physician before treatment
- •Provided two stool samples at baseline
- •Trichuris trichiura and hookworm EPG ≥ 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and hookworm eggs
排除标准
- •Pregnant or lactating and/or planning to become pregnant within three months after drug treatment
- •Type 1 and/or 2 diabetes
- •Psychiatric disorders
- •History of ophthalmological conditions
- •Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment
- •Suffers from severe anaemia (Hb < 80 g/l)
- •Received anthelminthic treatment within past four weeks
- •Attending other clinical trials during the study
- •Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin
- •Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir
研究组 & 干预措施
Emodepside 5 mg
干预措施: Emodepside (Drug)
Emodepside 10 mg
干预措施: Emodepside (Drug)
Emodepside 15 mg
干预措施: Emodepside (Drug)
Emodepside 20 mg
干预措施: Emodepside (Drug)
Emodepside 25 mg
干预措施: Emodepside (Drug)
Emodepside 30 mg
干预措施: Emodepside (Drug)
Albendazole
干预措施: Emodepside (Drug)
Placebo
干预措施: Emodepside (Drug)
结局指标
主要结局
Cure rate (CR) of emodepside against Trichuris trichiura
时间窗: In the week between 14 and 21 days post-treatment
CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
Cure rate (CR) of emodepside against hookworm
时间窗: In the week between 14 and 21 days post-treatment
CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.
次要结局
- CR against Ascaris lumbricoides(In the week between 14 and 21 days post-treatment)
- ERR against Ascaris lumbricoides(In the week between 14 and 21 days post-treatment)
- Geometric Mean Egg Reduction Rate (ERR) of the emodepside against Trichuris trichiura and hookworm.(In the week between 14 and 21 days post-treatment)
研究者
Jennifer Keiser
Prof. Dr.
Swiss Tropical & Public Health Institute