Azithromycin Reduction to Reach Elimination of Trachoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74,920
- 试验地点
- 1
- 主要终点
- Ocular chlamydia measured in a population-based sample of 0-9 year-old children
研究概览
简要总结
The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maradi, Niger. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of appropriate informed consent
- •Stated willingness to comply with all study procedures
- •Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
排除标准
- •Does not consent to participation
- •Unwilling to comply with all study procedures
- •Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
研究组 & 干预措施
Azithromycin Continuation
In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. Oral azithromycin, 20 mg/kg for children and 1 g for adults, will be offered to all households identified on the preceding census in the communities randomized to continuing treatment. Study drug will be distributed by health extension workers and organized by PNSO. Individuals with a known macrolide allergy will be offered a two-week course of daily ophthalmic tetracycline ointment (two tubes).
干预措施: Azithromycin (Drug)
结局指标
主要结局
Ocular chlamydia measured in a population-based sample of 0-9 year-old children
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)