Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma.
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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DOI：
10.1186/s12886-020-01776-4
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发表时间：
2021-01-06
影响因子：
2
通讯作者：
Oldenburg CE
中科院分区：
文献类型：
--
作者：
Amza A;Kadri B;Nassirou B;Arzika AM;Austin A;Nyatigo F;Lebas E;Arnold BF;Lietman TM;Oldenburg CE
世界卫生组织（WHO）建议每年大规模分发阿奇霉素，直到各地区沙眼性炎症-滤泡性（TF）患病率降至5%以下。TF患病率非常低的地区可能很少或没有导致沙眼的沙眼衣原体眼部菌株的传播，并且额外轮的大规模阿奇霉素分发可能没有用。在这里，我们描述了一个随机对照试验的协议，旨在评估是否大规模阿奇霉素分布可以停止之前，目前世界卫生组织的指南。阿奇霉素减少至达到消除沙眼（ARRET）研究是一项1：1社区随机非劣效性试验，旨在评估在TF基线患病率低于20%的地区是否可以停止大规模阿奇霉素分布。在基线评估后，将尼日尔马拉迪的社区随机分为继续每年大规模分发阿奇霉素或停止每年分发阿奇霉素3年。我们将比较眼部C。沙眼（主要结果），TF和其他沙眼临床体征，以及3年后的沙眼血清学标志物。我们假设，停止每年阿奇霉素分布将不劣于继续每年阿奇霉素分布的所有标志物的沙眼患病率和传播。这项试验的结果预计将提供潜在的指南改变证据时，大规模阿奇霉素分布可以停止在低TF患病率地区。本研究注册于clinicaltrials.gov（NCT 04185402）。2019年12月4日注册;前瞻性注册预结果。
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.
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影响因子：
120.7
作者：
Chidambaram, JD;Alemayehu, W;Lietman, TM
通讯作者：
Lietman, TM
影响因子：
3.8
作者：
Oldenburg, Catherine E.;Arzika, Ahmed M.;Lietman, Thomas M.
通讯作者：
Lietman, Thomas M.
影响因子：
1.8
作者：
Wilson, Nana;Goodhew, Brook;Martin, Diana L.
通讯作者：
Martin, Diana L.
影响因子：
3.8
作者：
Goodhew EB;Priest JW;Moss DM;Zhong G;Munoz B;Mkocha H;Martin DL;West SK;Gaydos C;Lammie PJ
通讯作者：
Lammie PJ
影响因子：
15.8
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通讯作者：
Keenan JD