AVENIR (infants)
Trial question
What is the role of azithromycin in infants 1-11 months of age?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
50.0% female
50.0% male
N = 177984
177984 patients (88481 female, 89503 male).
Inclusion criteria: infants 1-11 months of age in Niger.
Key exclusion criteria: known allergy to macrolides; receipt of treatment prior to sample collection.
Interventions
N=79310 azithromycin (20 mg/kg oral suspension twice yearly in infants 1-11 months of age).
N=98674 placebo (matching placebo twice yearly).
Primary outcome
Incidence of death in infants 1-11 months of age
22.3 /1K py
23.9 /1K py
23.9/1K py
17.9/1K py
11.9/1K py
6.0/1K py
0.0/1K py
Azithromycin
Placebo
Borderline significant
decrease ▼
Borderline significant decrease in the incidence of death in infants 1-11 months of age (22.3 deaths /1000 py vs. 23.9 deaths /1000 py; AD -6 deaths /1000 py, 95% CI -19 to 8).
Secondary outcomes
No significant difference in the incidence of death in children 12-59 months of age (12.2 deaths /1000 py vs. 12 deaths /1000 py; AD 0.2 deaths /1000 py, 95% CI -9 to 12).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In infants 1-11 months of age in Niger, azithromycin was not superior to placebo with respect to the incidence of death in infants 1-11 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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