CHAT
Trial question
What is the role of azithromycin administered during routine early infancy vaccination visits?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 32877
32877 patients (16181 female, 16696 male)
Inclusion criteria: infants recruited at routine vaccination or other well-child visits in clinics and through community outreach
Key exclusion criteria: allergy to macrolides or azalides; child unable to feed PO; children < 28 days old or > 12 weeks; children in bi-annual drug administration group weighing < 3.8 kg
Interventions
N=16416 azithromycin (oral administration of a single dose of 20 mg/kg of body weight)
N=16461 placebo (matching placebo dose)
Primary outcome
Rate of death before 6 months of age
0.52
0.48
0.5 %
0.4 %
0.3 %
0.1 %
0.0 %
Azithromycin
Placebo
No significant
difference ↔
No significant difference in the rate of death before 6 months of age (0.52% vs. 0.48%; HR 1.09, 95% CI 0.8 to 1.49)
Secondary outcomes
No significant difference in hospitalization (1.2% vs. 1.2%; RR 0.97, 95% CI 0.79 to 1.19)
No significant difference in sick-child clinic visit (36.9% vs. 36.4%; RR 1.02, 95% CI 0.98 to 1.06)
No significant difference in sick-child clinic visit for diarrhea (6.6% vs. 6.3%; RR 1.04, 95% CI 0.95 to 1.14)
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In infants recruited at routine vaccination or other well-child visits in clinics and through community outreach, azithromycin was not superior to placebo with respect to the rate of death before 6 months of age.
Reference
Ali Sié, Mamadou Ouattara, Mamadou Bountogo et al. Azithromycin during Routine Well-Infant Visits to Prevent Death. N Engl J Med. 2024 Jan 18;390(3):221-229.
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