Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa
Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa
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DOI：
10.1056/nejmoa1715474
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发表时间：
2018-04-26
影响因子：
158.5
通讯作者：
Lietman, T. M.
中科院分区：
文献类型：
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作者：
Keenan, J. D.;Bailey, R. L.;Lietman, T. M.
研究背景我们假设，向学龄前儿童大规模分发广谱抗生素制剂将降低撒哈拉以南非洲地区的死亡率，这些地区目前还远远没有达到联合国的可持续发展目标。和坦桑尼亚的四个每年两次的质量分布的口服阿奇霉素（约20毫克每公斤体重）或安慰剂。在每年两次的人口普查中确定了1至59个月的儿童，并提供了参与试验的机会。在随后的人口普查中确定生命状态。主要结果是总的全因死亡率;在预先指定的亚组分析中评估国家特异性死亡率。CITTSA共有1533个社区接受随机分组，在基线普查中确定了190，238名儿童，监测了323，302人年。在四个每年两次的分布中，阿奇霉素和安慰剂的平均（+/- SD）覆盖率为90.4 +/-10.4%。在接受阿奇霉素治疗的社区中，总的年死亡率为14.6例/1000人-年（马拉维9.1例，尼日尔22.5例，坦桑尼亚5.4例），在接受安慰剂治疗的社区中，总的年死亡率为16.5例/1000人-年（马拉维9.6例，尼日尔27.5例，坦桑尼亚5.5例）。接受阿奇霉素治疗的社区的死亡率比接受安慰剂治疗的社区低13.5%（95%置信区间[CI]，6.7 - 19.8）（P
BACKGROUNDWe hypothesized that mass distribution of a broad-spectrum antibiotic agent to preschool children would reduce mortality in areas of sub-Saharan Africa that are currently far from meeting the Sustainable Development Goals of the United Nations.METHODSIn this cluster-randomized trial, we assigned communities in Malawi, Niger, and Tanzania to four twice-yearly mass distributions of either oral azithromycin (approximately 20 mg per kilogram of body weight) or placebo. Children 1 to 59 months of age were identified in twice-yearly censuses and were offered participation in the trial. Vital status was determined at subsequent censuses. The primary outcome was aggregate all-cause mortality; country-specific rates were assessed in prespecified subgroup analyses.RESULTSA total of 1533 communities underwent randomization, 190,238 children were identified in the census at baseline, and 323,302 person-years were monitored. The mean (+/- SD) azithromycin and placebo coverage over the four twice-yearly distributions was 90.4 +/- 10.4%. The overall annual mortality rate was 14.6 deaths per 1000 person-years in communities that received azithromycin (9.1 in Malawi, 22.5 in Niger, and 5.4 in Tanzania) and 16.5 deaths per 1000 person-years in communities that received placebo (9.6 in Malawi, 27.5 in Niger, and 5.5 in Tanzania). Mortality was 13.5% lower overall (95% confidence interval [CI], 6.7 to 19.8) in communities that received azithromycin than in communities that received placebo (P