AVENIR (children)
Trial question
What is the role of azithromycin in children 1-59 months of age?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
50.0% female
50.0% male
N = 224684
224684 patients (111920 female, 112764 male).
Inclusion criteria: children 1-59 months of age in Niger.
Key exclusion criteria: known allergy to macrolides; receipt of treatment prior to sample collection.
Interventions
N=126010 azithromycin (20 mg/kg oral suspension twice yearly in children 1-59 months of age).
N=98674 placebo (matching placebo twice yearly).
Primary outcome
Incidence of death in children 1-59 months of age
11.9 /1K py
13.9 /1K py
13.9/1K py
10.4/1K py
7.0/1K py
3.5/1K py
0.0/1K py
Azithromycin
Placebo
Significant
decrease ▼
Significant decrease in the incidence of death in children 1-59 months of age (11.9 deaths /1000 py vs. 13.9 deaths /1000 py; AD -14 deaths /1000 py, 95% CI -22 to -7).
Secondary outcomes
Significant decrease in the incidence of death in children 12-59 months of age (10.7 deaths /1000 py vs. 12 deaths /1000 py; AD -13 deaths /1000 py, 95% CI -21 to -4).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In children 1-59 months of age in Niger, azithromycin was superior to placebo with respect to the incidence of death in children 1-59 months of age.
Reference
Kieran S O'Brien, Ahmed M Arzika, Abdou Amza et al. Azithromycin to Reduce Mortality - An Adaptive Cluster-Randomized Trial. N Engl J Med. 2024 Aug 22;391(8):699-709.
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