Peterson Brittany, Arzika Ahmed, Maliki Ramatou, Abdou Amza, Aichatou Bawa, Bello Ismael M, Beidi Diallo, Galo Nasser, Harouna Nasser, Karamba Alio M, Mahamadou Sani, Abarchi Moustapha, Ibrahim Almou, Lebas Elodie, Liu Zijun, Brandt Carolyn, Colby Emily, Oldenburg Catherine E, Porco Travis C, Arnold Benjamin, Lietman Thomas M, O'Brien Kieran Sunanda
F. I. Proctor Foundation, University of California, San Francisco, California, USA.
Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.
BMJ Open. 2025 Mar 27;15(3):e097916. doi: 10.1136/bmjopen-2024-097916.
Azithromycin has been shown to reduce all-cause child mortality. This subgroup analysis investigates azithromycin's mortality impact by underweight status using (AVENIR) trial data.
The AVENIR trial randomised communities into three arms: azithromycin for children aged 1-59 months, azithromycin for infants aged 1-11 months or placebo. Weight-for-age z-score was used to categorise children into subgroups of either moderate to severe underweight or not and severe underweight or not.
2880 communities with a population of less than 2500 people in the Dosso and Tahoua regions of Niger that participated in the AVENIR trial were included.
97 572 children aged 1-59 months who had weight captured during at least one census participated.
Underweight subgroups had higher overall mortality compared with non-underweight subgroups. IRDs of deaths in children aged 1-11 months comparing communities receiving azithromycin to children 1-59 months of age to placebo were -6.2 deaths per 1000 person-years (95% CI -9.3 to -2.6) overall, -8.0 (95% CI -15.9 to -0.4) in the moderate to severe subgroup and -11.2 (95% CI -26.0 to -2.1) in the severe subgroup. Similar trends were noted in the azithromycin 1-11 month comparison. Malnutrition was not a statistically significant effect modifier for either comparison.
Although analyses suggest the potential for stronger effects in more severe underweight subgroups, we were unable to demonstrate underweight status as an effect modifier. In fact, azithromycin mass drug administration to children 1-59 months old reduced mortality in all subgroups, and, especially as the number of lives saved would be the highest by treating all subgroups, our results do not support restricting eligibility for this intervention.
clinicaltrials.gov NCT04224987.
阿奇霉素已被证明可降低儿童全因死亡率。本亚组分析利用非洲阿奇霉素试验（AVENIR）数据，按体重不足状况研究阿奇霉素对死亡率的影响。
AVENIR试验将社区随机分为三组：1至59个月儿童使用阿奇霉素组、1至11个月婴儿使用阿奇霉素组或安慰剂组。采用年龄别体重Z评分将儿童分为中度至重度体重不足或非体重不足以及重度体重不足或非体重不足亚组。
纳入了尼日尔多索和塔胡阿地区2880个社区，这些社区人口不足2500人，参与了AVENIR试验。
97572名1至59个月的儿童参与，他们在至少一次普查中记录了体重。
体重不足亚组的总体死亡率高于非体重不足亚组。将接受阿奇霉素治疗的社区中1至11个月儿童与1至59个月接受安慰剂治疗的儿童相比，1至11个月儿童的死亡发病率总体为每1000人年-6.2例死亡（95%置信区间-9.3至-2.6），中度至重度亚组为-8.0（95%置信区间-15.9至-0.4），重度亚组为-11.2（95%置信区间-26.0至-2.1）。在阿奇霉素1至11个月组的比较中也观察到类似趋势。营养不良对这两种比较均无统计学意义的效应修饰作用。
尽管分析表明在更严重的体重不足亚组中可能有更强的效果，但我们无法证明体重不足状况是一种效应修饰因素。事实上，对1至59个月大的儿童进行阿奇霉素群体给药可降低所有亚组的死亡率，而且，特别是通过治疗所有亚组挽救的生命数量将是最多的，我们的结果不支持限制该干预措施的适用资格。
clinicaltrials.gov NCT04224987。
