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临床试验/NCT02373657
NCT02373657已完成不适用

Water Uptake for Health in Amhara Pilot

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 4,068 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,068
试验地点
1
主要终点
Prevalence of soil transmitted helminths (Ascaris, Trichuris trichiura, and hookworm) (0-5 year olds)

研究概览

简要总结

Trachoma is a blinding disease caused by ocular strains of Chlamydia trachomatis. The Carter Center and Proctor Foundation have been jointly conducting trachoma research in the Goncha Siso Enese woreda of Amhara for the past 8 years, through a series of clinical trials. We have found that repeated mass administration of oral azithromycin can greatly reduce the prevalence of trachoma, but mass antibiotics have been unable thus far to eliminate infection. The World Health Organization recommends not only antibiotics for control of trachoma, but an entire SAFE strategy (Surgery for in-turned eyelids, Antibiotics, Facial hygiene promotion, and Environmental improvements such as latrines and water points). Trachoma is more common in villages and households with poor access to water and latrines, so improving the public health infrastructure is thought to be important for limiting transmission of trachoma. However, there is very little evidence to support the efficacy of installing new water points for trachoma. There has been only one previous attempt to study the role of hand dug well installation for trachoma control, and this study, conducted in Niger, found that installing wells was not effective. We now propose a project to improve the public health infrastructure of Goncha Siso Enese woreda by helping with the construction of water points (e.g., hand-dug wells) and providing hygiene education, in order to determine whether improving access to water and hygiene information will be effective for control of trachoma and soil-transmitted helminths.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • All residents residing in the state-teams which are randomly selected for this study.

排除标准

  • Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

结局指标

主要结局

Prevalence of soil transmitted helminths (Ascaris, Trichuris trichiura, and hookworm) (0-5 year olds)

时间窗: 24 months

Prevalence of ocular chlamydia infection (0-5 year olds)

时间窗: 24 months

Nasopharyngeal macrolide resistance (0-5 year olds)

时间窗: 24 months

次要结局

  • Clinically active trachoma in children aged 0-5, as determined by the WHO simplified grading system(24 months)
  • Childhood growth (weight controlled for height among children aged 0-5 years at baseline)(24 months)
  • Prevalence of enteric viruses using PCR (0-5 year olds)(24 months)
  • Self report childhood morbidity(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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