NCT01050517已完成不适用
Gaps in Helminth Control: Safety and Efficacy of Drug Combinations Against Triple Infections
DBL -Institute for Health Research and Development1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- adverse reactions
研究概览
简要总结
This randomised, controlled, double blinded clinical study investigates the safety and efficacy of the combination of albendazole, ivermectin and praziquantel in the treatment of children aged 5-18 years co-infected with lymphatic filariasis, schistosomiasis and soil-transmitted helminthiasis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who will be in class one to six by the time of study
- •Aged 5-18 years and found infected with either SCH, any STH or LF for treatment groups 1,2 or 3 or infected with both SCH and LF for treatment group 4 and infected with all the three for treatment group 5
- •Who are willing and consent and whose parents will consent, will be included in the study.
排除标准
- •Those with acute and chronic diseases other than the targeted infections and those with a history of any serious adverse drug reactions will not be included in the study.
- •Children with total bilirubin > 50µmol/L and ALAT (Alanine transferase) > 70IU/L will not qualify for recruitment.
研究组 & 干预措施
1
Active Comparator
albendazole + ivermectin + praziquantel
干预措施: albendazole + ivermectin + praziquantel (Drug)
2
Placebo Comparator
albendazole + ivermectin + (1 week later) praziquantel
干预措施: albendazole + ivermectin + (1 week later) praziquantel (Drug)
结局指标
主要结局
adverse reactions
时间窗: 6 weeks
次要结局
- Efficacy of treatment(6 weeks)
研究者
研究点 (1)
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