Effect of Mass Distribution of Azithromycin for Trachoma Control on Overall Mortality in Ethiopian Children A Randomized Trial
Effect of Mass Distribution of Azithromycin for Trachoma Control on Overall Mortality in Ethiopian Children A Randomized Trial
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DOI：
10.1001/jama.2009.1266
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发表时间：
2009-09-02
影响因子：
120.7
通讯作者：
Lietman, Thomas M.
中科院分区：
文献类型：
--
作者：
Porco, Travis C.;Gebre, Teshome;Lietman, Thomas M.
向受影响的社区大规模分发口服阿奇霉素是世界卫生组织消除沙眼计划的基石。提供抗生素以靶向导致沙眼的衣原体的眼部菌株，但也可以有效地对抗呼吸道疾病、腹泻和疟疾-沙眼流行区儿童死亡的常见原因。目的比较治疗社区与未治疗社区中1至9岁参与者的死亡率。设计，设置，我们进行了一项大规模使用阿奇霉素控制沙眼的随机分组临床试验。48个社区（称为subkebeles）被随机分为3个治疗方案之一（所有居民每年治疗[15902名参与者]，所有居民每两年治疗[17288名参与者]，或仅儿童每季度治疗[14716名参与者]）或1组治疗延迟1年（对照组，18498名参与者）。12个subkebeles被随机分配到4个时间表中的每一个，3个社区的所有儿童都有资格接受治疗。该试验于2006年5月至2007年5月在埃塞俄比亚农村进行。干预措施给予单剂量口服阿奇霉素（成人，1 g;儿童，20 mg/kg）治疗眼部沙眼衣原体感染。1至9岁儿童的抗生素覆盖水平在所有访问中均超过80%.Main Outcome Measure主要结果指标是1至9岁儿童在1年内的社区特定死亡风险。在基线和1年后再次通过计数普查测量死亡率。死亡率的风险比较是一个预先设定的outcome for the clinical trial.Results干预社区儿童死亡率的比值比为0.51（95%可信区间，0.29-0.90; P= 0.02;聚类logistic回归）与对照组相比。在接受治疗的社区中，未接受治疗组1至9岁儿童在此期间的估计总死亡率为每1000人年8.3人（95%置信区间，5.3-13.1），而在接受治疗的社区中，估计的总体死亡率为每1000人年4.1人（95%可信区间，3.0-5.7）为1至9岁的儿童。结论在沙眼流行区，口服阿奇霉素的大量分布与儿童死亡率降低有关clinicaltrials.gov。2009;302（9）：962-968 www.jama.com
Context Mass oral azithromycin distribution to affected communities is a cornerstone of the World Health Organization's trachoma elimination program. Antibiotics are provided to target the ocular strains of chlamydia that cause trachoma, but may also be efficacious against respiratory disease, diarrhea, and malaria-frequent causes of childhood mortality in trachoma-endemic areas.Objective To compare mortality rates of participants aged 1 to 9 years in treated communities with those in untreated communities.Design, Setting, and Participants We conducted a cluster-randomized clinical trial of mass azithromycin administration for trachoma control. Forty-eight communities (known as subkebeles) were randomized into 1 of 3 treatment schedules (annual treatment of all residents [15 902 participants], biannual treatment of all residents [17 288 participants], or quarterly treatment of children only [14 716 participants]) or into 1 group for which treatment was delayed by 1 year (control, 18 498 participants). Twelve subkebeles were randomized to each of the 4 schedules with all children in each of the 3 communities being eligible for treatment. The trial was conducted in a field setting in rural Ethiopia, May 2006 to May 2007.Interventions A single dose of oral azithromycin (adults, 1 g; children, 20 mg/kg) was administered for treatment of ocular Chlamydia trachomatis infection. Antibiotic coverage levels for children aged 1 to 9 years exceeded 80% at all visits.Main Outcome Measure The main outcome measure was the community-specific mortality risk for children aged 1 to 9 years over the course of 1 year. Mortality was measured by enumerative census at baseline and again after 1 year. Comparison of the risk of mortality was a prespecified outcome for the clinical trial.Results The odds ratio for childhood mortality in the intervention communities was 0.51 (95% confidence interval, 0.29-0.90; P=.02; clustered logistic regression) compared with the control group. In the treated communities, the estimated overall mortality rate during this period for children aged 1 to 9 years in the untreated group was 8.3 per 1000 person-years (95% confidence interval, 5.3-13.1), while among the treated communities, the estimated overall mortality rate was 4.1 per 1000 person-years (95% confidence interval, 3.0-5.7) for children aged 1 to 9 years.Conclusion In a trachoma-endemic area, mass distribution of oral azithromycin was associated with reduced mortality in children.Trial Registration clinicaltrials.gov Identifier: NCT00322972 JAMA. 2009;302(9):962-968 www.jama.com