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首页> 外文期刊>PLoS Medicine >Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II)
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Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II)

机译：一项集群随机试验后，阿奇霉素在高流行性沙眼中的分布：一项随机重新分配的亚类（TANA II）的继续研究

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Background The World Health Organization recommends annual mass azithromycin administration in communities with at least 10% prevalence of trachomatous inflammation–follicular (TF) in children, with further treatment depending on reassessment after 3–5 years. However, the effect of stopping mass azithromycin distribution after multiple rounds of treatment is not well understood. Here, we report the results of a cluster-randomized trial where communities that had received 4 years of treatments were then randomized to continuation or discontinuation of treatment. Methods and findings In all, 48 communities with 3,938 children aged 0–9 years at baseline in northern Ethiopia had received 4 years of annual or twice yearly mass azithromycin distribution as part of the TANA I trial. We randomized these communities to either continuation or discontinuation of treatment. Individuals in the communities in the continuation arm were offered either annual or twice yearly distribution of a single directly observed dose of oral azithromycin. The primary outcome was community prevalence of ocular chlamydial infection in a random sample of children aged 0–9 years, 36 months after baseline. We also assessed the change from baseline to 36 months in ocular chlamydia prevalence within each arm. We compared 36-month ocular chlamydia prevalence in communities randomized to continuation versus discontinuation in a model adjusting for baseline ocular chlamydia prevalence. A secondary prespecified analysis assessed the rate of change over time in ocular chlamydia prevalence between arms. In the continuation arm, mean antibiotic coverage was greater than 90% at all time points. In the discontinuation arm, the mean prevalence of infection in children aged 0–9 years increased from 8.3% (95% CI 4.2% to 12.4%) at 0 months to 14.7% (95% CI 8.7% to 20.8%, P = 0.04) at 36 months. Ocular chlamydia prevalence in communities where mass azithromycin distribution was continued was 7.2% (95% CI 3.3% to 11.0%) at baseline and 6.6% (95% CI 1.1% to 12.0%, P = 0.64) at 36 months. The 36-month prevalence of ocular chlamydia was significantly lower in communities continuing treatment compared with those discontinuing treatment (P = 0.03). Limitations of the study include uncertain generalizability outside of trachoma hyperendemic regions. Conclusions In this study, ocular chlamydia infection rebounded after 4 years of periodic mass azithromycin distribution. Continued distributions did not completely eliminate infection in all communities or meet WHO control goals, although they did prevent resurgence. Trial registration This study was prospectively registered at clinicaltrials.gov (clinicaltrials.gov NCT01202331 ).
机译：背景世界卫生组织建议在儿童中沙眼气管炎-小卵泡（TF）患病率至少为10％的社区中每年进行阿奇霉素的大规模管理，并根据3-5年后的重新评估进行进一步治疗。然而，在多轮治疗后停止阿奇霉素的大量分布的效果还不是很清楚。在这里，我们报告了一项整群随机试验的结果，该试验将接受4年治疗的社区随机分为继续治疗或终止治疗。方法和发现作为TANA I试验的一部分，埃塞俄比亚北部共有48个社区，有3,938名年龄在0-9岁的儿童在基线时接受了4年或每年两次的阿奇霉素大规模分发。我们将这些社区随机分为继续治疗或终止治疗。连续臂社区中的个人每年或一次直接口服阿奇霉素剂量的两次分发。主要结果是在基线后36个月的0-9岁儿童的随机样本中眼衣原体感染的社区患病率。我们还评估了从基线到36个月各臂内眼衣原体患病率的变化。我们在调整基线眼衣原体患病率的模型中，比较了36个月的眼衣原体患病率在随机分配为连续还是终止的社区中进行。预先进行的次要分析评估了两臂间眼衣原体患病率随时间的变化率。在继续治疗组中，所有时间点的平均抗生素覆盖率均大于90％。在停药组中，0-9岁儿童的平均感染率在0个月时从8.3％（95％CI 4.2％增至12.4％）增至14.7％（95％CI 8.7％至20.8％，P = 0.04 ）在36个月时。在基线继续阿奇霉素持续大量分布的社区，眼衣原体患病率在基线时为7.2％（95％CI为3.3％至11.0％），在36个月时为6.6％（95％CI为1.1％至12.0％，P = 0.64）。与停止治疗的社区相比，继续治疗的社区的眼衣原体感染的36个月患病率明显更低（P = 0.03）。该研究的局限性包括沙眼高流行区以外的不确定的普遍性。结论在本研究中，眼部衣原体感染在周期性的阿奇霉素周期性分布4年后反弹。尽管继续分发确实阻止了死灰复燃，但并不能完全消除所有社区的感染或达到WHO的控制目标。试验注册本研究已在Clinicaltrials.gov（clinicaltrials.gov NCT01202331）上进行了前瞻性注册。

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