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临床试验/NCT02176057
NCT02176057撤回2 期

Nepal Elimination of Trachoma Study

University of California, San Francisco1 个研究点 分布在 1 个国家开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Trachoma (clinical and C. trachomatis)

研究概览

简要总结

The main purpose of this study is to determine if ocular Chlamydia trachomatis infection can be eliminated in communities in Nepal following mass antibiotic distributions with azithromycin. The investigators will study both clinical trachoma and ocular C. trachomatis infection. The overall objective is to determine if the current World Health Organization (WHO) treatment strategy results in elimination of trachoma and infection.

  1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease <5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.

  2. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensiti1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease <5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.

  3. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensitive nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).ve nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).

详细描述

Here we evaluate whether ocular chlamydia infection and clinical trachoma are eliminated from 24 communities in western Nepal following a mass antibiotic distribution program. It is unknown if repeated treatments should continue or can be stopped thereby minimizing side effects and the high cost of medicine distribution. The investigators plan to randomize individuals to two groups to study the effects of a mass antibiotic distribution program: 1) treatment of antibiotics and 2) delayed treatment of antibiotics (after 4-6 months).

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, Care Provider)

入排标准

年龄范围
1 Year 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 1-9 years
  • Children who live in Kailai, Kanchanpur, or Achham Districts of Nepal

排除标准

  • All individuals who are allergic to macrolides
  • All pregnant woman
  • All neonates

研究组 & 干预措施

Antibiotic

Experimental

Azithromycin, suspension (liquid), 1 gram, one-time dose

干预措施: Azithromycin (Drug)

结局指标

主要结局

Trachoma (clinical and C. trachomatis)

时间窗: 12 months

次要结局

  • Anthropometry (height for weight)(12 months)
  • Malaria(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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