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首页> 外文期刊>BMC Ophthalmology >Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma
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Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma

机译：减少氮霉素，以达到沙眼（arret）的消除：研究方案，用于集群随机试验停止体重瘤霉素分布的沙眼

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The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation—follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether mass azithromycin distribution can be stopped prior to the current WHO guidelines. The Azithromycin Reduction to Reach Elimination of Trachoma (ARRET) study is a 1:1 community randomized non-inferiority trial designed to evaluate whether mass azithromycin distribution can be stopped in districts with baseline prevalence of TF under 20%. Communities in Maradi, Niger are randomized after baseline assessment either to continued annual mass azithromycin distribution or stopping annual azithromycin distribution over a 3-year period. We will compare the prevalence of ocular C. trachomatis (primary outcome), TF and other clinical signs of trachoma, and serologic markers of trachoma after 3?years. We hypothesize that stopping annual azithromycin distribution will be non-inferior to continued annual azithromycin distributions for all markers of trachoma prevalence and transmission. The results of this trial are anticipated to provide potentially guideline-changing evidence for when mass azithromycin distributions can be stopped in low TF prevalence areas. This study is registered at clinicaltrials.gov ( NCT04185402 ). Registered December 4, 2019; prospectively registered pre-results.
机译：世界卫生组织（世卫组织）建议年群众氮霉素分布，直到地区下降低于16％的毛细血管炎症（TF）。 TF流行率非常低的地区可能几乎没有或没有传播衣原体衣原体的眼部菌株，导致沙眼的衣原体，并且额外的大规模氮霉素分布可能没有有用。在这里，我们描述了用于评估当前谁之前可以停止大规模氮霉素分布是否可以停止的随机对照试验的方案。减少达到沙眼（Arret）研究的氮霉素减少是1：1社区随机的非劣效性试验，旨在评估大规模氮素霉素分布是否可以在2岁以下的地区停止。在基线评估后，尼日尔的群落在基线评估后随机化，无论是在3年内持续年度大规模氮素霉素分布或停止年度氮杂霉素分布。我们将比较眼睛C. Thachomatis（初级结果），TF和其他临床迹象的患病率，3年后的沙眼和沙眼的血清素标志物。我们假设停止年度氮杂霉素分布将不逊于持续的每年阿奇霉素分布，用于沙眼普遍和传输的所有标志。预计此试验的结果将提供可能导致的改变据指导性改变证据，以便在低TF流行区域停止群众氮霉素分布时。本研究在ClinicalTrials.gov（NCT04185402）注册。注册2019年12月4日;潜在注册的预期结果。

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