Safety of azithromycin in infants under six months of age in Niger: A community randomized trial
Safety of azithromycin in infants under six months of age in Niger: A community randomized trial
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DOI：
10.1371/journal.pntd.0006950
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发表时间：
2018-11-01
影响因子：
3.8
通讯作者：
Lietman, Thomas M.
中科院分区：
文献类型：
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作者：
Oldenburg, Catherine E.;Arzika, Ahmed M.;Lietman, Thomas M.
大规模分发阿奇霉素可降低5岁以下儿童死亡率。沙眼控制计划目前治疗6个月及以上的婴儿。在这里，我们报告了在尼日尔进行的一项大型社区随机试验中，对接受阿奇霉素治疗的1-5个月奥尔兹婴儿进行的不良事件调查的结果。从一项大型随机分组试验中随机选择30个社区，进行为期5个月的治疗，该试验是一项两年一次的大规模阿奇霉素分布试验，与安慰剂相比，影响儿童死亡率。我们比较了阿奇霉素治疗与安慰剂治疗婴儿治疗后不良事件的分布。从2015年1月到2018年2月，对1,712名婴儿的照顾者进行了调查。大约三分之一的看护者报告了至少一起不良事件（阿奇霉素：29.6%，安慰剂：34.3%，风险比[RR] 0.86，95%置信区间[CI] 0.68至1.10，P = 0.23）。最常报告的不良事件包括腹泻（阿奇霉素：19.3%，安慰剂：28.1%，RR 0.68，95% CI 0.49 - 0.96，P = 0.03），呕吐（阿奇霉素：15.9%，安慰剂：21.0%，RR 0.76，95% CI 0.56 - 1.02，P = 0.07）和皮疹（阿奇霉素：12.3%，安慰剂：13.6%，RR 0.90，95% CI 0.59 - 1.37，P = 0.63）。没有婴儿肥厚性幽门狭窄的病例reported.ConclusionsAzithromycin给1-5个月的婴儿似乎是安全的。如果认为有效，可以考虑将年龄较小的婴儿纳入更大的阿奇霉素为基础的儿童死亡率或沙眼控制计划。
BackgroundMass azithromycin distribution reduces under-5 child mortality. Trachoma control programs currently treat infants aged 6 months and older. Here, we report findings from an infant adverse event survey in 1-5 month olds who received azithromycin as part of a large community-randomized trial in Niger.Methods and principal findingsActive surveillance of infants aged 1-5 months at the time of treatment was conducted in 30 randomly selected communities from within a large cluster randomized trial of biannual mass azithromycin distribution compared to placebo to assess the potential impact on child mortality. We compared the distribution of adverse events reported after treatment among azithromycin-treated versus placebo-treated infants. From January 2015 to February 2018, the caregivers of 1,712 infants were surveyed. Approximately one-third of caregivers reported at least one adverse event (azithromycin: 29.6%, placebo: 34.3%, risk ratio [RR] 0.86, 95% confidence interval [CI] 0.68 to 1.10, P = 0.23). The most commonly reported adverse events included diarrhea (azithromycin: 19.3%, placebo: 28.1%, RR 0.68, 95% CI 0.49 to 0.96, P = 0.03), vomiting (azithromycin: 15.9%, placebo: 21.0%, RR 0.76, 95% CI 0.56 to 1.02, P = 0.07), and skin rash (azithromycin: 12.3%, placebo: 13.6%, RR 0.90, 95% CI 0.59 to 1.37, P = 0.63). No cases of infantile hypertrophic pyloric stenosis were reported.ConclusionsAzithromycin given to infants aged 1-5 months appeared to be safe. Inclusion of younger infants in larger azithromycin-based child mortality or trachoma control programs could be considered if deemed effective.