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临床试验/NCT01087099
NCT01087099已完成4 期

A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children

University Ghent7 个研究点 分布在 7 个国家目标入组 1,750 人开始时间: 2009年1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
1,750
试验地点
7
主要终点
Efficacy of albendazole

研究概览

简要总结

The three major Soil-Transmitted Helminths (STH), Ascaris lumbricoides, Necator americanus/Ancylostoma duodenal and Trichuris trichiura are among the most prevalent parasites worldwide. The objective of this multicentre international study is to define the efficacy of a single 400 milligram dose of albendazole (ALB) against these three STHs using a standardised protocol. The trial will be undertaken among school age children in seven countries - Brazil, Cameroon, Cambodia, Ethiopia, India, Tanzania (Zanzibar) and Vietnam - each with a different epidemiologic pattern of infection. A trial of this nature is urgently required because in spite of the wide usage of albendazole over the last 3 decades, there is still no key publication reporting the efficacy of the anthelmintic accurately, and to modern conventional standards, that can act as a central reference for the baseline efficacy. The latter is critically important because albendazole is now being used even more widely, as large scale mass treatment campaigns are being implemented in Africa and elsewhere, with the intention of reducing morbidity in children. Such large scale usage of a drug risks resistance developing, but resistance cannot be detected unless benchmark values for baseline efficacy are widely known.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children should be infected with a minimum of 150 eggs/gram of any of the three species of STH (i.e. Ascaris or hookworms or Trichuris).

排除标准

  • Not willing to participate
  • Unable to give samples for follow up
  • Severe intercurrent medical condition
  • Diarrhoea at first sampling

研究组 & 干预措施

Albendazole

Experimental

Treatment with albendazole

干预措施: Albendazole (Drug)

结局指标

主要结局

Efficacy of albendazole

时间窗: 14 to 30 days after treatment

To determine the efficacy of albendazole, and this will be assessed by the reduction in parasite faecal egg counts between the pre- and post-intervention surveys. The latter will be conducted 14-30 days after treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (7)

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