Kebele Elimination of Trachoma for Ocular Health
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
- 否
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
Annual mass azithromycin distribution of all residents
干预措施: Azithromycin (Drug)
Age-based core group
Annual mass azithromycin treatment of everyone plus quarterly treatment of children
干预措施: Azithromycin (Drug)
PCR infection-based core group
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
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)
