Trachoma Elimination With Repeated Mass Azithromycin Treatments
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- The prevalence of ocular chlamydia infection in a village as determined by PCR
研究概览
简要总结
The WHO has initiated a program to eliminate blinding trachoma by the year 2020, in large part by mass oral azithromycin distributions. It is not clear how frequently or for how long these treatments are necessary. Here we assess the frequency and duration of treatment.
详细描述
40 villages in the Gurage Zone of Ethiopia were randomly assigned to biannual treatment, annual treatment, and a single treatment. Each treatment consisted of a single dose of oral azithromycin to the entire population over the age of 1 year (when the study was started, azithromycin had not yet been approved for ages below 1 year). We assess the prevalence the ocular chlamydia that causes trachoma in the peak prevalence age of 1-5 years at baseline, and 2, 6, 12, 18, and 24 months post treatment. An extension of the study monitors infection at 30 and 36 months post treatment. Untreated villages from the same area are enrolled in a step-wedge design to assess the presence of a secular trend. A random sample of those not within the 1-5 year old age group are examined to assess the prevalence of infection in the entire community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 to 5 years old in a village in the Gurage zone with endemic trachoma
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
The prevalence of ocular chlamydia infection in a village as determined by PCR
次要结局
- Clinical active trachoma, as determined by the WHO simplified grading system, by village