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

描述（由申请人提供）：拟议项目的目的是确定一个综合的水和卫生一揽子计划是否是一种具有成本效益的战略，以加速消除沙眼。大量使用阿奇霉素可有效清除引起沙眼的眼部衣原体菌株，但不能消除受影响最严重地区的沙眼。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。由于卫生条件差被认为是沙眼的一个重要危险因素，世界卫生组织建议改善沙眼的非抗生素卫生（例如，厕所、供水和促进洗脸）。然而，从未有任何随机临床试验证明这些措施可以预防眼衣原体的传播，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。目前的报告试图填补这一空白，将埃塞俄比亚的社区随机分配到一揽子卫生干预措施或标准护理中。在试验中，所有社区都将接受单剂量口服阿奇霉素。随机分配到卫生包的社区将获得水井、厕所和洗脸教育。随机分配到标准护理的社区将接受政府目前提供的卫生促进服务。该试验的共同主要结果将是在基线随访后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PCR的衣原体负荷和鼻咽肺炎球菌大环内酯耐药性。将进行成本效益分析，以便沙眼项目更好地决定如何利用有限的资源。相关性（见说明）：沙眼仍然是世界范围内致盲的主要传染性原因。沙眼在贫困地区最为常见，卫生条件差被认为是一个促成因素。然而，没有临床试验表明改善公共卫生和卫生对沙眼有效。该试验旨在为指导沙眼控制非抗生素措施的决策提供更有力的证据基础。

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.