Tripartite International Research for the Elimination of Trachoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29,000
- 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 36 months versus 0 months for Aim 1, at 36 months for Aim 2 and Aim 3)
研究概览
简要总结
Mass antimicrobial administrations have been remarkably successful in reducing the prevalence of the ocular strains of Chlamydia that cause trachoma. Repeated distributions progressively lower the prevalence of infection, and in some cases may even result in local elimination. Mass treatments cannot be continued forever, due to concerns about cost and antibiotic resistance. The hope has been that other measures such as latrine construction and hygiene programs would prevent infection from returning. Unfortunately, no non-antibiotic measure has yet demonstrated an effect on infection.
- We hypothesize that Chlamydial infection will return to communities when treatment ends.
- We hypothesize that infection will be completely eliminated in all communities treated for seven years.
- We hypothesize that identifying and treating clinically active cases among preschool aged children will delay or even prevent reemergence at a far lower cost than mass treatment of all individuals.
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 continue to monitor a sub-set of communities from our TANA study, in Goncha Siso Enese district of East Gojam Zone, Ethiopia. Here we evaluate how infection returns when antibiotics are discontinued, whether infection can be predictably eliminated, and whether infection can be prevented from returning with targeted treatment strategies:
Specific Aim 1. To determine whether antibiotics can be stopped after 4 years.
Specific Aim 2. To determine whether infection can be completely eliminated if mass treatments continue for seven years.
Specific Aim 3. To determine whether treatment targeted to pre-school aged children, or to households in which a pre-school aged child has clinically active trachoma, will prevent infection from returning into the community.
Specific Aim 4: To determine whether mass azithromycin distributions reduce visits to local health clinics due to all causes and infectious causes.
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 Day 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
L
Continue Annual Treatment
干预措施: mass treatment with oral azithromycin (Drug)
M
Continue Biannual Treatment
干预措施: mass treatment with oral azithromycin (Drug)
N
Targeted Treatment by Age
干预措施: mass treatment with oral azithromycin (Drug)
O
Targeted Treatment by Clinical Exam
干预措施: mass treatment with oral azithromycin (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 36 months versus 0 months for Aim 1, at 36 months for Aim 2 and Aim 3)
时间窗: 36 months
次要结局
- Clinical active trachoma in community, as determined by the WHO simplified grading system(36 months)
- Childhood mortality (6 months -5 years of age), 6-10 years of age, and >10 years(36 months)
- Health clinic visits (due to all causes and due to infectious causes) in children aged 6 months-5 years, 6-10 years, and >10 years(36 months)
- Prevalence of anemia (hemoglobin levels in 0-9 year olds) and the prevalence of malaria(36 months)
- Estimate of chlamydial load from real-time, qPCR(0, 12, 24, 36 months)
- Anthropometric measurements (weight and height), as outlined by WHO child growth standards (0-5 years of age)(3, 12, 24, and 36 months after baseline)
- Clinically active trachoma in a school (all children under age 10), as determined by the WHO simplified grading system(36 months)
- Cost-effectiveness of mass azithromycin administration, per infection year prevented and cost per eliminated village(0, 12, 24, and 36 months)
- Macrolide resistance in pneumococcus, Haemophilus influenzae, and Staphylococcus aureus (% resistance over time, clustered by randomization unit)(36 months)
研究者
Thomas M. Lietman
Professor
University of California, San Francisco