1. In this randomized cluster trial, twice-yearly azithromycin distribution reduced all-cause childhood mortality among children aged one to 59 months in rural communities in Niger.

2. Distribution of azithromycin was not effective at reducing infant mortality when only given to children one to 11 months of age. 

Evidence Rating Level: 1 (Excellent)

Study Rundown: All-cause childhood mortality risk remains an area of concern in Sub-Saharan Africa, with nearly 10% of children passing before their fifth birthday. Previous studies have shown that twice-yearly mass distributions of azithromycin may be an effective way of reducing mortality risk in children in high-mortality settings. The World Health Organization recommends restricting distribution to infants one to 11 months of age to minimize the risk of antimicrobial resistance, though this specific intervention has yet to be investigated. The present trial investigated two-year all-cause mortality risk after twice-yearly distributions of azithromycin to children in Niger. The study evaluated mortality risk among children one to 59 months of age and infants one to 11 months of age. Compared to placebo, twice-yearly azithromycin distribution significantly lowered mortality among children one to 59 months of age but not in the one to 11 months of age group. The study was limited by its simplified design, sample size, inability to assess antimicrobial resistance, and restricted patient population, given that recruitment was conducted in two regions in Niger. Overall, these findings demonstrated that twice-yearly azithromycin distribution to children one to 59 months of age reduced mortality and was more beneficial than limiting distribution to children one to 11 months of age.

Click here to read the study in NEJM

Relevant Reading: Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa

In-Depth [randomized cluster trial]: This cluster randomized trial assessed the effect of four twice-yearly azithromycin distributions on childhood mortality in children aged one to 59 months and infants one to 11 months. Children aged one to 59 months who weighed at least 3kg with no known history of macrolide antibiotic allergies were eligible to participate. A total of 3,000 communities in Niger were randomly assigned to one of three groups: child azithromycin group (azithromycin distribution twice yearly to children one to 59 months of age; n=1273), infant azithromycin group (azithromycin distribution twice yearly to children one to 11 months of age and placebo to children 12 to 59 months; n=773), or placebo (twice yearly placebo distribution to children one to 59 months of age n=954). Three primary outcomes were evaluated, where two-year community mortality outcomes were examined for each age group and paired group comparisons. After two years, children one to 59 months of age had lower observed mortality than placebo (95% Confidence Interval [CI], 7-22; p<0.001). When comparing the infant azithromycin group to placebo, infants one to 11 months of age did not have significantly reduced mortality compared to placebo. Among children 12 to 59 months of age, mortality was lower in children receiving azithromycin than those receiving the placebo (95% (CI), 4-21). These results provided evidence that twice yearly distribution of azithromycin was effective at reducing mortality in children aged 1 to 59 months in Niger.

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