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临床试验/NCT01327469
NCT01327469已完成4 期

The Efficacy of 5 Anthelmintic Regimes Against T. Trichiura Infections in Schoolchildren in Jimma, Ethiopia

University Ghent1 个研究点 分布在 1 个国家目标入组 2,250 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
2,250
试验地点
1
主要终点
Efficacy against T. trichiura of various treatment regimes

研究概览

简要总结

The major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the most prevalent parasites worldwide. An estimated 4.5 billion individuals are at risk for STH and more than one billion individuals are thought to be infected, of which 450 million have significant morbidity attributable from their infection, school-aged children in particular. In this population infections cause stunting of the linear growth, anemia, reduce the cognitive function and contribute to the existing malnutrition. In Jimma (Ethiopia), STH are highly prevalent, affecting more than 60% of the children (data not published).

Current efforts to control STH infections involve periodic mass drug anthelmintic treatment of infected children in endemic areas and are likely to intensify as more attention is addressed to the importance of these neglected diseases. Monitoring drug efficacy in these control programs has become indispensable in order to detect the emergence of resistance and/or identify confounding factors affecting the drug efficacy. Recently a study has evaluated a single dose albendazole (ALB) in school age children across 7 countries, including Ethiopia, revealing that this regime is highly efficacious for the treatment of A. lumbricoides (99.5%) and hookworms (94.8%), but not for T. trichiura (50.8%). For this parasite a repeated dose regime of ALB on consecutive days is likely to be more appropriate. Alternative drugs are mebendazole (single dose 500mg) and pyrantel+oxantel (single dose 10mg/kg), of which the latter holds promise as it can also be administrated to children between 6 months and 2 years. The main objective of the present study, therefore, is to assess the efficacy of 5 different treatment regimes against T. trichiura in schoolchildren in Jimma, Ethiopia, including albendazole (1 x 400mg, 2 x 400mg), mebendazole (1 x 500mg, 2x 500mg) and pyrantel-oxantel (10mg/kg)+mebendazole (500mg).

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
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • all school age children who are eligible to participate in the study

排除标准

  • Not willing to participate (no informed consent)
  • Unable to give samples for follow up
  • Severe intercurrent medical condition
  • Diarrhea at first sampling
  • Study subjects who had treatment for STH in the last 3 months

研究组 & 干预措施

Albendazole 400mg

Experimental

albendazole, 1 x 400mg

干预措施: Albendazole 400mg (Drug)

Albendazole 2 x 400mg

Experimental

albendazole, 2 x 400mg

干预措施: Albendazole, 2 x 400mg (Drug)

Mebendazole 500mg

Experimental

mebendazole, 1 x 500mg

干预措施: Mebendazole 500mg (Drug)

Mebendazole 2 x 500mg

Experimental

mebendazole, 2x 500mg

干预措施: Mebendazole 2 x 500mg (Drug)

Pyrantel-oxantel + mebendazole

Experimental

pyrantel-oxantel (10mg/kg)+ mebendazole (500mg)

干预措施: Pyrantel-oxantel + mebendazole (Drug)

结局指标

主要结局

Efficacy against T. trichiura of various treatment regimes

时间窗: After two weeks treatment

The evaluation of the efficacy against T. trichiura of various treatment regimes. To this end, subjects infected with T. trichura (based on McMaster), will be randomly assigned to one of the five proposed treatment regimes. Two weeks after the treatment, faecal egg counts will be performed and the reduction in faecal egg counts will be evaluated

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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