Sanitation, Water, and Instruction in Face-washing for Trachoma

说明(由申请人提供)：拟议项目的目的是确定全面的水和卫生一揽子计划是否是加速消除沙眼的具有成本效益的战略。大量使用阿奇霉素可以有效清除引起沙眼的眼部衣原体感染，但不能消除受影响最严重的地区的沙眼。此外，大规模抗生素治疗的缺点是在共生生物中选择耐药性。由于恶劣的卫生被认为是沙眼的一个重要风险因素，世界卫生组织建议对沙眼进行非抗生素卫生改进(例如，厕所、供水和推广洗脸)。然而，从来没有随机临床试验证明这些措施中的任何一项都可以防止眼衣原体的传播，甚至没有进行过将世卫组织推荐的整套干预措施一起实施的试验。目前提交的材料试图填补这一空白，将埃塞俄比亚的社区随机分配到一揽子卫生干预措施或护理标准。在试验中，所有社区都将接受单剂阿奇霉素口服。被随机纳入卫生方案的社区将获得水井、厕所和洗脸教育。随机进入护理标准的社区将得到目前由政府提供的卫生促进服务。试验的共同主要结果将是在基线访问后36个月临床沙眼和眼衣原体患病率的改善。次要结果将包括定量聚合酶链式反应的衣原体载量和鼻咽肺炎球菌对大环内酯类药物的耐药性。将进行成本效益分析，以使沙眼项目能够更好地决定如何利用其有限的资源。相关性(见说明)：沙眼仍然是世界范围内导致失明的主要传染病。沙眼在贫困地区最常见，卫生条件差被认为是一个促成因素。然而，还没有临床试验表明，改善公共卫生和卫生对沙眼有效。这项试验寻求提供更有力的证据基础，以指导关于控制沙眼的非抗生素措施的决定。

DESCRIPTION (provided by applicant): The aim of the proposed project is to determine whether a comprehensive water and sanitation package is a cost-effective strategy to hasten trachoma elimination. Mass azithromycin distributions are effective in clearing the ocular strains bf chlamydia that cause trachoma, but do not eliminate trachoma in the most severely affected areas. Moreover, mass antibiotic treatments have the disadvantage of selecting for resistance among commensal organisms. Because poor hygiene is thought to be an important risk factor for trachoma, the World Health Organization recommends non-antibiotic hygiene improvements for trachoma (e.g., latrines, water supply, and promotion of face washing). However, no randomized clinical trial has ever demonstrated that any of these measures prevent transmission of ocular chlamydia, and no trials have even been conducted in which the entire package of WHO-recommended interventions are implemented together. The current submission attempts to fill that gap, by randomizing communities in Ethiopia to either a package of hygiene interventions, or to standard of care. In the trial, all communities will receive a singe dose of oral azithromycin. Communities randomized to the hygiene package will receive wells, latrines, and education on face washing. Communities randomized to standard of care will receive the current hygiene promotion services provided by the government. The co-primary outcomes of the trial will be improvement in clinical trachoma and the prevalence of ocular chlamydia at 36 months after the baseline visit. Secondary outcomes will include chlamydial load from quantitative PCR and nasopharyngeal pneumococcal macrolide resistance. A cost-effectiveness analysis will be performed to allow trachoma programs to better decide how to use their limited resources. RELEVANCE (See instructions): Trachoma remains the leading infectious cause of blindness worldwide. Trachoma is most common in areas of poverty, with poor hygiene thought to be a contributing factor. However, there have been no clinical trials demonstrating that improvements in public health and hygiene are effective for trachoma. This trial seeks to provide a stronger evidence base to guide decisions on non-antibiotic measures for trachoma control.