Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II).
Mass azithromycin distribution for hyperendemic trachoma following a cluster-randomized trial: A continuation study of randomly reassigned subclusters (TANA II).
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DOI：
10.1371/journal.pmed.1002633
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发表时间：
2018-08
期刊：
影响因子：
15.8
通讯作者：
Lietman TM
中科院分区：
文献类型：
--
作者：
Keenan JD;Tadesse Z;Gebresillasie S;Shiferaw A;Zerihun M;Emerson PM;Callahan K;Cotter SY;Stoller NE;Porco TC;Oldenburg CE;Lietman TM
世界卫生组织建议在儿童沙眼性炎症-滤泡（TF）患病率至少为10%的社区每年大规模使用阿奇霉素，并根据3-5年后的重新评估进一步治疗。然而，在多轮治疗后停止大量阿奇霉素分布的效果尚不清楚。在这里，我们报告了一项随机分组试验的结果，在该试验中，接受了4年治疗的社区被随机分为继续治疗或停止治疗。作为TANA I试验的一部分，埃塞俄比亚北方48个社区共3,938名0-9岁儿童接受了为期4年的每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组和停止治疗组。继续组社区的个体每年或每年两次接受一次直接观察剂量的口服阿奇霉素。主要结果是在基线后36个月，随机抽取0-9岁儿童样本，观察眼部衣原体感染的社区患病率。我们还评估了从基线到36个月的变化，眼衣原体患病率在每组。我们比较了36个月的眼衣原体患病率在社区随机继续与中止模型调整基线眼衣原体患病率。一项预先规定的次要分析评估了两组间眼部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岁儿童的平均感染患病率从0个月时的8.3%（95% CI 4.2%至12.4%）增加至36个月时的14.7%（95% CI 8.7%至20.8%，P = 0.04）。在继续大规模分发阿奇霉素的社区中，基线时眼衣原体患病率为7.2%（95% CI 3.3%至11.0%），36个月时为6.6%（95% CI 1.1%至12.0%，P = 0.64）。36个月的患病率眼衣原体是显着较低的社区继续治疗相比，那些停止治疗（P = 0.03）。该研究的局限性包括沙眼高流行地区以外的不确定的普遍性。在这项研究中，眼部衣原体感染反弹后，4年的周期性大规模阿奇霉素分布。继续分发疫苗并没有完全消除所有社区的感染，也没有达到世卫组织的控制目标，尽管它们确实防止了疫情的复发。本研究在clinicaltrials.gov（clinicaltrials.gov NCT 01202331）进行前瞻性注册。Catherine E Oldenburg及其同事研究了继续或停止抗生素预防衣原体眼部感染的影响。沙眼是世界上主要的致盲性传染病。虽然沙眼在全球范围内正在消失，但在埃塞俄比亚的一些地区仍然存在严重的沙眼。定期大规模分发阿奇霉素可将感染降至很低水平，但在所有社区完全消除已被证明是困难的。我们评估了在埃塞俄比亚北方严重沙眼社区治疗4年后是否可以停止大规模阿奇霉素的分发。一个参加过先前随机分组试验的社区子集被重新随机分组，继续或停止大规模阿奇霉素的分发。在停止大规模分发阿奇霉素后，发现引起沙眼的眼部衣原体感染随着时间的推移而增加。与继续大规模分发阿奇霉素的社区相比，在3年的研究后，停止分发阿奇霉素的社区的眼部衣原体感染率显著较高。尽管在社区进行了7年的治疗，继续大规模分发阿奇霉素，但并没有在所有社区消除感染。沙眼可能是第一个由公共卫生计划消除的人类细菌性疾病;然而，这些结果表明，在一些严重受影响的地区停止大规模阿奇霉素治疗是不现实的。对于受影响最严重的地区，可能需要替代性的沙眼消除战略。
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. 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. 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. This study was prospectively registered at clinicaltrials.gov (clinicaltrials.gov NCT01202331). Catherine E Oldenburg and colleagues investigate effects of continuing or stopping antibiotic prophylaxis for chlamydial eye infection. Trachoma is the leading infectious cause of blindness in the world. Although trachoma is disappearing globally, severe trachoma persists in a few districts in Ethiopia. Periodic mass azithromycin distribution reduces infection to very low levels, but complete elimination in all communities has proven difficult. We assessed whether mass azithromycin distributions could be discontinued after 4 years of treatment in communities with severe trachoma in northern Ethiopia. A subset of communities that had participated in a previous cluster-randomized trial were re-randomized to continuation or discontinuation of mass azithromycin distribution. Ocular chlamydia infection, which causes trachoma, was found to increase over time after mass azithromycin distribution was stopped. Compared to communities where mass azithromycin distribution was continued, communities where distribution was stopped had significantly higher rates of ocular chlamydia infection after 3 years of study. Despite 7 years of treatment in communities continuing mass azithromycin distribution, infection was not eliminated in all communities. Trachoma may be the first bacterial disease of humans to be eliminated by a public health program; however, these results indicate that stopping mass azithromycin treatment in some severely affected areas is not realistic. Alternative strategies for trachoma elimination may be required for the most severely affected areas.
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