Twice-yearly distribution of azithromycin has been shown to reduce all-cause childhood mortality among children aged 1 to 59 months in rural communities in Niger, according to a recent randomized cluster trial. The study, published in the New England Journal of Medicine, challenges the World Health Organization's recommendation to restrict distribution to infants aged 1 to 11 months, as this intervention was not found to be effective in reducing infant mortality.
The research was conducted in Niger, where childhood mortality remains a significant concern, with nearly 10% of children dying before their fifth birthday. Previous studies have suggested that mass azithromycin distributions could be an effective way to reduce mortality risk in high-mortality settings. This trial aimed to investigate the impact of twice-yearly azithromycin distributions on two-year all-cause mortality risk in children.
The trial involved 3,000 communities in Niger, randomly assigned to one of three groups: a child azithromycin group (azithromycin for children aged 1-59 months), an infant azithromycin group (azithromycin for children aged 1-11 months and placebo for those aged 12-59 months), or a placebo group. The primary outcome was two-year community mortality in each age group.
Key Findings
After two years, the study found that children aged 1 to 59 months in the azithromycin group had significantly lower mortality compared to the placebo group (95% CI, 7-22; p<0.001). However, infants aged 1 to 11 months in the azithromycin group did not have significantly reduced mortality compared to the placebo group. Among children aged 12 to 59 months, mortality was lower in those receiving azithromycin than those receiving the placebo (95% CI, 4-21).
Implications and Context
These results suggest that twice-yearly distribution of azithromycin is effective at reducing mortality in children aged 1 to 59 months in Niger. The study's findings challenge the current WHO recommendation to limit distribution to infants aged 1 to 11 months, indicating that a broader distribution strategy may be more beneficial. The researchers noted the study was limited by its simplified design, sample size, inability to assess antimicrobial resistance, and restricted patient population.
The study adds to the growing body of evidence supporting the use of azithromycin to reduce childhood mortality in Sub-Saharan Africa. Further research is needed to assess the long-term impact of azithromycin distribution on antimicrobial resistance and to optimize distribution strategies for maximum impact.