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临床试验/NCT03335072
NCT03335072进行中(未招募)4 期

Kebele Elimination of Trachoma for Ocular Health

University of California, San Francisco2 个研究点 分布在 2 个国家目标入组 320,000 人开始时间: 2022年2月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
320,000
试验地点
2
主要终点
Ocular chlamydia measured in a population based age-stratified sample of the entire community

研究概览

简要总结

The investigators propose a cluster-randomized clinical trial to determine whether an intensive, targeted azithromycin distribution strategy is effective for elimination of trachoma at the kebele level compared to the World Health Organization (WHO) recommendation of annual azithromycin distribution.

详细描述

The investigators propose to randomize at the kebele level, which consist of approximately 15 villages, 4,000 residents, and are served by a single primary school. Eighty kebeles will be randomized to one of four arms: 1) annual mass azithromycin distribution per WHO guidelines (Annual); 2) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years (Core Group-Age); 3) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years with a positive chlamydial PCR test (Core Group-PCR); or 4) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years positive for conjunctival inflammation as assessed from annual photography (Core Group-TI). The primary outcome for the trial will be the ocular chlamydia prevalence at 12, 24, and 36 months. Secondary outcomes will include bacterial load of ocular chlamydia via quantitative PCR, the prevalence of clinically active trachoma assessed at 12, 24, and 36 months, and serology via dried blood spot at baseline and 36 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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • All individuals in all communities will be eligible for annual mass azithromycin distribution per WHO guidelines.

排除标准

  • Those who do not consent.

研究组 & 干预措施

WHO-recommended

Active Comparator

Annual mass azithromycin distribution of all residents

干预措施: Azithromycin (Drug)

Age-based core group

Experimental

Annual mass azithromycin treatment of everyone plus quarterly treatment of children

干预措施: Azithromycin (Drug)

PCR infection-based core group

Experimental

Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group.

干预措施: Azithromycin (Drug)

TI-based core group

Experimental

Annual mass azithromycin treatment plus quarterly treatment of a conjunctival photography-based cohort that would be a subset of the age-based core group

干预措施: Azithromycin (Drug)

结局指标

主要结局

Ocular chlamydia measured in a population based age-stratified sample of the entire community

时间窗: 36 months

Assessed by PCR

次要结局

  • Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia(36 months)
  • Conjunctival inflammation(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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