Eliminating Trachoma With Repeat Mass Drug Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33,000
- 试验地点
- 1
- 主要终点
- The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 42 months for Aim 1, at 12 months for Aim 2, post-treatment relative to pre-treatment for Aim 3)
研究概览
简要总结
The WHO has initiated a program to eliminate trachoma, blinding eye infection caused by Chlamydia trachomatis, in large part by mass distributions of oral azithromycin. The proposed study will determine the frequency and treatment target of community-wide mass antibiotic treatment. We will also study the impact of mass antibiotic distribution on antibiotic-resistance in pneumococcus.
详细描述
The proposed study is a group-randomized trial to determine the frequency and treatment target of community-wide mass antibiotic treatment to eliminate trachoma. We will also study the impact of community-wide antibiotic distribution on antibiotic-resistance in pneumococcus. Communities in Goncha Siso Enese district of East Gojam Zone, Ethiopia will be randomly assigned to different treatment schemes and monitored to study the following research questions:
Specific Aim 1. To determine whether biannual mass treatments is more likely to eliminate ocular chlamydia from hyper-endemic communities than annual mass treatments.
Specific Aim 2. To determine whether children form a core group for the transmission of trachoma.
Specific Aim 3. To determine whether latrine construction prevents the return of infection into a community after mass treatment.
Specific Aim 4. To determine the effect of mass azithromycin treatments on antibiotic resistance in pneumococcus and the reduction in mortality.
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
- Single (Outcomes Assessor)
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
- 是
入选标准
- •All residents residing in the state-teams which are randomly selected for this study.
排除标准
- •Pregnant women
- •Children under 6 months of age
- •All those who are allergic to macrolides or azalides
- •Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
- •Individuals in these three exclusion criteria will not be given the study antibiotic azithromycin, but offered the current WHO-recommended alternative treatment to azithromycin for active trachoma, which is 1% tetracycline eye ointment, to be used twice a day, topically to both eyes, for six weeks. Note that the exclusion criteria refer to the exclusion to the treatment drug, but not to the monitoring, treatment of trachoma, and examinations.
研究组 & 干预措施
A
Annual mass treatment
干预措施: Mass treatment with oral azithromycin to an entire community (Drug)
B
Biannual mass treatment
干预措施: Mass treatment with oral azithromycin to an entire community (Drug)
C
Mass administration of antibiotic; treatment of children (1-10 years of age) only
干预措施: Mass treatment with oral azithromycin to an entire community (Drug)
F
One-time mass administration only
干预措施: Mass treatment with oral azithromycin to an entire community (Drug)
G
One-time mass administration of antibiotics, plus intensive latrine construction
干预措施: Mass treatment with oral azithromycin to an entire community (Drug)
结局指标
主要结局
The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 42 months for Aim 1, at 12 months for Aim 2, post-treatment relative to pre-treatment for Aim 3)
时间窗: 42 months
次要结局
- Diversity measure in the conjunctival and nasopharyngeal microbiomes of children (age 0-9)(0, 6, 12, 18, 24, 30, 36, 42, and 48 months)
- Childhood (>= 1 year of age) mortality, analyzed as 1-5, 6-10 years of age, and total(42 months)
- Average prevalence of ocular chlamydia infection in annually and biennially treated communities as determined by pooled NAAT (Nucleic Acid Amplification Test)(48 months)
- Clinical active trachoma in community, as determined by the WHO simplified grading system(42 months)
- Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit)(42 months)
研究者
Thomas M. Lietman
Professor
University of California, San Francisco