NCT07258173尚未招募2 期
Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita: a Phase II, Randomized, Double Blind, Controlled Trial
Jennifer Keiser0 个研究点目标入组 100 人开始时间: 2026年11月15日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Cure rate (CR) of emodepside compared to albendazole against Trichuris incognita
研究概览
简要总结
The purpose of this clinical trial is to compare the efficacy and safety of emodepside with the standard treatment, albendazole, in adolescents (12 years and older) and adults infected with Trichuris incognita.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12 years and above.
- •Written informed consent signed by participant and, in the case of minors, parents/caregivers.
- •Agree to comply with study procedures, including provision of two stool samples at the beginning (screening) and at follow-up assessment 14-21 days after treatment.
- •Having at least two slides of the quadruple Kato-Katz thick smears positive for Trichuris incognita and infection intensities of at least 48 eggs per gram (EPG).
- •Willing to be examined by a study physician prior to treatment.
排除标准
- •Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38 °C, severe anemia (Hb below 80g/l) upon initial clinical assessment etc.
- •History of severe acute or unmanaged severe chronic disease (i.e., condition is not as therapeutically controlled as necessary).
- •Positive malaria rapid diagnostic test (RDT) and temperature ≥ 38 °C.
- •Abnormal liver and renal function assessed by biochemical blood-based analyses.
- •Recent use of anthelmintic drugs (in the 4 weeks before treatment).
- •Known allergy to study medications and formulations (i.e. albendazole and emodepside).
- •Prescribed or taking medication with known contraindication to or interaction with study drugs.
- •Participating in other clinical trials during the study period.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Albendazole 400 mg
Active Comparator
干预措施: Albendazole 400 mg (Drug)
Emodepside 15mg
Experimental
干预措施: Emodepside (Drug)
结局指标
主要结局
Cure rate (CR) of emodepside compared to albendazole against Trichuris incognita
时间窗: Between 14-21 days post-treatment
Trichuris incognita infection status of participants 14-21 days post-treatment assessed by Kato-Katz. CRs will be calculated as the percentage of egg-positive participants at screening who become egg-negative after treatment, for each treatment arm. Differences in CRs between the two treatments will be assessed.
次要结局
- Egg-reduction rate (ERR) of emodepside compared to albendazole against Trichuris incognita(Between 14-21 days post-treatment)
- Safety and tolerability(3- and 24- hours post-treatment and retrospectively 14-21 days post-treatment)
研究者
Jennifer Keiser
Professor
Swiss Tropical & Public Health Institute
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