Community-based Approach for the Management of Soil-transmitted Helminthiasis in General and Strongyloidiasis in Particular in a Highly Endemic Area
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy
研究概览
简要总结
The general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a highly endemic area in northern Argentina with a multidisciplinary approach. The specific objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology method for S. stercoralis and evaluate the efficacy and safety of a mass drug administration regimen with albendazole and ivermectin.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All persons that are living in the working area at the time of the intervention and wish to participate in the study.
排除标准
- •All persons that live within the study area but do not want to participate in the study.
- •Pregnant women or women who are likely pregnant.
- •Women during the first post-partum week if they are breastfeeding.
- •Children who weigh less than 15 kg.
- •Persons with a history of hypersensitivity or intolerance to ivermectin, albendazole or to the components that make up those drugs.
结局指标
主要结局
Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy
时间窗: 15 months
Evaluate local epidemiology of STH: frequency of species, prevalence and intensity of infections, groups more affected, morbidity. Evaluate the efficacy of a single-dose anti-helminthic regimen for community treatments: albendazole 400 mg + ivermectin 200 mcg/kg.
次要结局
- Validate serology methods for diagnosis of S. stercoralis infection(15 months)
- Assess the tolerability and safety of the combination of ivermectin and albendazole(15 months)