Background

Evidence regarding the appropriate duration of treatment with antibiotic agents in children with pneumonia in low-resource settings in Africa is lacking.

Methods

We conducted a double-blind, randomized, controlled, noninferiority trial in Lilongwe, Malawi, to determine whether treatment with amoxicillin for 3 days is less effective than treatment for 5 days in children with chest-indrawing pneumonia (cough lasting <14 days or difficulty breathing, along with visible indrawing of the chest wall with or without fast breathing for age). Children not infected with human immunodeficiency virus (HIV) who were 2 to 59 months of age and had chest-indrawing pneumonia were randomly assigned to receive amoxicillin twice daily for either 3 days or 5 days. Children were followed for 14 days. The primary outcome was treatment failure by day 6; noninferiority of the 3-day regimen to the 5-day regimen would be shown if the percentage of children with treatment failure in the 3-day group was no more than 1.5 times that in the 5-day group. Prespecified secondary analyses included assessment of treatment failure or relapse by day 14.

Results

From March 29, 2016, to April 1, 2019, a total of 3000 children underwent randomization: 1497 children were assigned to the 3-day group, and 1503 to the 5-day group. Among children with day 6 data available, treatment failure had occurred in 5.9% in the 3-day group (85 of 1442 children) and in 5.2% (75 of 1456) in the 5-day group (adjusted difference, 0.7 percentage points; 95% confidence interval [CI], −0.9 to 2.4) — a result that satisfied the criterion for noninferiority of the 3-day regimen to the 5-day regimen. Among children with day 14 data available, 176 of 1411 children (12.5%) in the 3-day group and 154 of 1429 (10.8%) in the 5-day group had had treatment failure by day 6 or relapse by day 14 (between-group difference, 1.7 percentage points; 95% CI, −0.7 to 4.1). The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group).

Conclusions

In HIV-uninfected Malawian children, treatment with amoxicillin for chest-indrawing pneumonia for 3 days was noninferior to treatment for 5 days. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT02678195.)

中文翻译：

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马拉维儿童吸入性肺炎阿莫西林需要3或5天。

背景

在非洲资源贫乏地区，缺乏关于对肺炎患儿使用抗生素治疗适当时间的证据。

方法

我们在马拉维的利隆圭进行了一项双盲，随机，对照，非劣效性试验，以确定在患有吸胸性肺炎的儿童中（咳嗽持续<14天或有困难），阿莫西林治疗3天是否比5天治疗无效呼吸，以及随着年龄的增长而有或没有快速呼吸的胸壁明显缩回。年龄在2至59个月之间且未感染人免疫缺陷病毒（HIV）的儿童，且患有抽搐性肺炎，被随机分配接受阿莫西林治疗，每天两次，连续3天或5天。对儿童进行了14天的随访。主要结果是到第6天治疗失败。如果在3天组中治疗失败的儿童比例不超过1，则显示3天方案与5天方案的非劣效性。5天组的5倍。预先指定的二级分析包括评估第14天治疗失败或复发的情况。

结果

从2016年3月29日到2019年4月1日，共有3000名儿童接受了随机分组：1497名儿童被分配到3天小组中，1503名儿童被分配到5天小组中。在可获得第6天数据的儿童中，三天组（1442名儿童中的85名）的治疗失败发生率为5.9％，五天组中5.2％（1456名儿童中的75名）的治疗失败发生率（调整后的差异为0.7个百分点； 95％置信区间[CI]，-0.9至2.4）-结果满足3天方案对5天方案的非劣效性标准。在可获得第14天数据的儿童中，第3天组的1411名儿童中有176名（12.5％），第5天组的154名1429名儿童（10.8％）在第6天出现治疗失败或在第14天（之间）复发组差异为1.7个百分点； 95％CI为-0.7至4.1）。

结论

在未感染HIV的马拉维儿童中，用阿莫西林治疗3 d的吸入性肺炎效果不逊于治疗5 d。（由比尔和梅琳达·盖茨基金会资助； ClinicalTrials.gov编号，NCT02678195。）