NCT05538767已完成2 期
Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials
Jennifer Keiser1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2022年9月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Cure rate (CR) of emodepside against hookworm
研究概览
简要总结
To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults aged between 12 and 60 years;
- •Written and signed informed consent;
- •Was examined by a study physician before treatment;
- •Provided two stool samples at baseline;
- •Hookworm EPG > 48 and at least two Kato-Katz thick smears slides with more than one 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.
- •Participated in stage I trials of this protocol
研究组 & 干预措施
Emodepside 30 mg
Experimental
干预措施: Emodepside (Drug)
Albendazole 400 mg
Active Comparator
干预措施: Albendazole 400mg (Drug)
结局指标
主要结局
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
- Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2.(At baseline and 14-21 days post-treatment)
- Geometric Mean Egg Reduction Rate (ERR) of the emodepside against hookworm.(In the week between 14 and 21 days post-treatment)
- CR of emodepside against Trichuris trichiura and Ascaris lumbricoides(In the week between 14 and 21 days post-treatment)
- ERR of the emodepside against Trichuris trichiura and Ascaris lumbricoides.(In the week between 14 and 21 days post-treatment)
研究者
Jennifer Keiser
Prof. Dr.
Swiss Tropical & Public Health Institute
研究点 (1)
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