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The AVENIR trial, a large-scale study conducted in Niger, provides compelling evidence on the effectiveness of azithromycin distribution in reducing childhood mortality. This cluster-randomized trial compared different strategies for azithromycin distribution among children in rural communities, offering insights into the optimal approach for implementing this intervention in high-mortality settings.
Key Points:
- Twice-yearly azithromycin distribution to children aged 1-59 months reduced all-cause mortality by 14% compared to placebo (11.9 vs 13.9 deaths per 1000 person-years; 95% CI, 7-22%; P<0.001).
- Azithromycin distribution limited to infants aged 1-11 months did not significantly reduce mortality compared to placebo (22.3 vs 23.9 deaths per 1000 person-years; 95% CI, -8 to 19%).
- Treating all children aged 1-59 months with azithromycin resulted in 17% lower mortality among infants 1-11 months compared to treating only infants (18.5 vs 22.3 deaths per 1000 person-years; 95% CI, 4-28%).
- The trial demonstrated azithromycin’s effectiveness in reducing mortality even in the presence of seasonal malaria chemoprevention and in areas with lower baseline mortality rates than previous studies.
- Only five serious adverse events were reported across all groups, with none attributed to azithromycin by medical monitors.
- The study used an innovative response-adaptive randomization design, allowing for ethical optimization of community assignments to the most effective intervention over time.
HCN Medical Memo
The AVENIR trial provides strong evidence supporting the broader distribution of azithromycin to children aged 1-59 months in high-mortality settings, challenging current WHO guidelines that recommend limiting distribution to infants aged 1-11 months. Physicians should consider these findings when implementing or advocating for child mortality reduction strategies in similar contexts.
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