NCT03995680已完成2 期
Efficacy and Safety of a New Chewable Tablet of Mebendazole Versus the Swallowable, Standard Tablet of Mebendazole Against Hookworm Infections in Children: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 1
- 主要终点
- Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm
研究概览
简要总结
The rational of this study is to provide evidence on the safety and efficacy of a new chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged children 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
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female children aged between 3 and 12 years;
- •Written informed consent signed by caregiver;
- •Was examined by a study physician before treatment;
- •Provided two stool samples at baseline;
- •Hookworm EPG > 100 and at least two Kato-Katz thick smears slides with more than one hookworm egg;
排除标准
- •Pregnant;
- •Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, such as can upon initial clinical assessment;
- •Suffers from severe anemia (Hb < 80 g/l);
- •Received anthelminthic treatment or metronidazole within past four weeks.
- •Attending other clinical trials during the study.
研究组 & 干预措施
Chewable tablet of mebendazole
Experimental
- 3-5 year olds allocated to the swallowable tablet arm will be given the crushed tablet on a spoon mixed with a small amount of clean water;
- 6-12 year olds allocated to the swallowable tablet arm will be given the whole tablet to swallow with a glass of clean water;
干预措施: Mebendazole (Drug)
Swallowable tablet of mebendazole
Active Comparator
- 3-5 year olds allocated to the chewable tablet arm will be encouraged to chew the tablet and swallow it without water; if they cannot chew it then a small amount of water will be added to the tablet in a spoon;
- 6-12 year olds allocated to the chewable tablet arm will be encouraged to chew the tablet and then swallow it without water.
干预措施: Mebendazole (Drug)
结局指标
主要结局
Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm
时间窗: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).
次要结局
- Cure Rate (CR) of Mebendazole Against Hookworm(Baseline (before treatment) and sometime between 14 and 21 days post-treatment)
- CR of Both Mebendazole Regimens Against Trichuris Trichiura(Baseline (before treatment) and sometime between 14 and 21 days post-treatment)
- Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura(Baseline (before treatment) and sometime between 14 and 21 days post-treatment)
- CR of Both Mebendazole Formulations Against Ascaris Lumbricoides(Baseline (before treatment) and sometime between 14 and 21 days post-treatment)
- Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides.(Baseline (before treatment) and sometime between 14 and 21 days post-treatment)
- Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm(Baseline (before treatment) and sometime between 14 and 21 days post-treatment)
- Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura(Baseline (before treatment) and sometime between 14 and 21 days post-treatment)
- Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides(Baseline (before treatment) and sometime 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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