Mass azithromycin distribution and antibiotic resistance in the gut and nasopharynx: a cluster-randomized trial.

However, antibiotic resistance is a major public health concern as the program is being implemented in sub-Saharan Africa.

然而，随着该项目在撒哈拉以南非洲的实施，抗生素耐药性已成为一个主要的公共卫生问题。

In the double-blind, cluster-randomized, placebo-controlledtrial (AVENIR) in Niger, we evaluated the impact of azithromycin MDA targeting different age groups on mortality and on the gut and nasopharyngeal microbiome and resistome of children in participating communities.

在尼日尔进行的双盲、群组随机、安慰剂对照试验(AVENIR)中，我们评估了针对不同年龄组的阿奇霉素大规模治疗对参与社区儿童死亡率以及肠道和鼻咽部微生物组和耐药基因组的影响。

A total of 3,000 communities were randomized in a 1:1:1 allocation to 3 arms: 2 years of semiannual MDA of (1: child-azithromycin) azithromycin to 1-59-month olds, (2: infant-azithromycin) azithromycin to 1-11-month olds and placebo to 12-59-month olds or (3: placebo) placebo to 1-59-month olds.

共有3000个社区按照1:1:1的比例随机分配到3个组别：对1-59个月大的儿童进行两年的半年一次的阿奇霉素大规模治疗（1:儿童阿奇霉素组）；对1-11个月大的婴儿进行阿奇霉素大规模治疗（2:婴儿阿奇霉素组）和对12-59个月大的儿童给予安慰剂；或者（3:安慰剂组）对1-59个月大的儿童给予安慰剂。

Mortality (co-primary endpoint) and safety data have previously been published.

死亡率（共同主要终点）和安全性数据之前已发表。

Here we report on resistance (the co-primary endpoint).

在这里，我们报告了耐药性（共同主要终点）的数据。

One hundred fifty communities (50 per arm) were selected for this analysis.

本分析选取了150个社区，每个组别各50个。

A total of 4,382 rectal and 4,402 nasopharyngeal samples were included.

总共纳入了4,382个直肠样本和4,402个鼻咽样本。

The co-primary outcomes included changes in gut and nasopharynx macrolide AMR.

主要结果包括肠道和鼻咽部大环内酯类抗生素耐药性的变化。

The trial met its primary AMR endpoint for the gut but not for the nasopharynx.

该试验达到了肠道主要的抗生素耐药性终点，但未达到鼻咽部的终点。

The gut macrolide AMR burden in fold change between arms was highest in child-azithromycin compared with placebo (1.16, 95% confidence interval(CI): 1.06-1.28; P < 0.01), followed by child-azithromycin compared with infant-azithromycin (1.13, 95% CI: 1.02-1.23; P = 0.01), and infant-azithromycin compared with placebo (1.04×, 95% CI: 0.94-1.15×; P = 0.66).

肠道大环内酯类抗生素耐药性负担的倍数变化在各组之间最高的是儿童阿奇霉素与安慰剂相比（1.16，95%置信区间（CI）：1.06-1.28；P < 0.01），其次是儿童阿奇霉素与婴儿阿奇霉素相比（1.13，95% CI：1.02-1.23；P = 0.01），以及婴儿阿奇霉素与安慰剂相比（1.04倍，95% CI：0.94-1.15倍；P = 0.66）。

There were no statistically significant differences in macrolide AMR selection fold change in the nasopharynx between arms: 2.14 (95% CI: 0.93-4.99) for child-azithromycin versus placebo, 2.08 (95% CI: 0.93-4.69) for infant-azithromycin versus placebo, and 1.03 (95% CI: 0.46-2.30) for child-azithromycin versus infant-azithromycin.

在各组之间，鼻咽部大环内酯类抗生素耐药性选择的倍数变化没有统计学上的显著差异：儿童阿奇霉素与安慰剂相比为2.14（95% CI：0.93-4.99），婴儿阿奇霉素与安慰剂相比为2.08（95% CI：0.93-4.69），儿童阿奇霉素与婴儿阿奇霉素相比为1.03（95% CI：0.46-2.30）。

Close monitoring of AMR should be an essential component of MDA for childhood mortality.

对抗微生物耐药性(AMR)的密切监测应成为减少儿童死亡率的多部门行动计划(MDA)的一个基本组成部分。

ClinicalTrials.gov registration: NCT04224987.

临床试验注册：NCT04224987。