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Azithromycin during Routine Well-Infant Visits to Prevent Death
Ali Sié1, Mamadou Ouattara1, Mamadou Bountogo1
1From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.
Insights
Administering azithromycin to infants did not prevent death in Burkina Faso. This study found no reduction in infant mortality when azithromycin was given during routine health visits.
Area of Science:
- Global Health
- Pediatrics
- Infectious Diseases
Background:
- Mass azithromycin distribution reduces childhood mortality in some African regions, particularly in infants under 12 months.
- The effectiveness of routine infant healthcare visits for azithromycin administration in preventing infant death remains unclear.
Purpose of the Study:
- To evaluate the efficacy of single-dose azithromycin administered during infancy (5-12 weeks) via routine healthcare visits in preventing death before 6 months of age.
- To assess the impact of infant azithromycin on all-cause mortality in Burkina Faso.
Main Methods:
- A randomized, placebo-controlled trial involving 32,877 infants in Burkina Faso.
- Infants received either a single dose of azithromycin (20 mg/kg) or placebo during routine health visits.
- Primary endpoint was mortality before 6 months of age, with vital status assessed at 6 months.
Main Results:
- No significant difference in mortality was observed between the azithromycin group (82 deaths) and the placebo group (75 deaths) before 6 months of age.
- The hazard ratio for death was 1.09 (95% CI, 0.80 to 1.49), with no statistically significant effect found in prespecified subgroups.
- No difference in adverse events was noted between the two groups.
Conclusions:
- Administration of azithromycin to infants through the existing healthcare system in Burkina Faso did not prevent death.
- The findings suggest that this specific intervention strategy is not effective in reducing infant mortality in this context.
Background:
Mass distribution of azithromycin to children 1 to 59 months of age has been shown to reduce childhood all-cause mortality in some sub-Saharan African regions, with the largest reduction seen among infants younger than 12 months of age. Whether the administration of azithromycin at routine health care visits for infants would be effective in preventing death is unclear.
Methods:
We conducted a randomized, placebo-controlled trial of a single dose of azithromycin (20 mg per kilogram of body weight) as compared with placebo, administered during infancy (5 to 12 weeks of age). The primary end point was death before 6 months of age. Infants were recruited at routine vaccination or other well-child visits in clinics and through community outreach in three regions of Burkina Faso. Vital status was assessed at 6 months of age.
Results:
Of the 32,877 infants enrolled from September 2019 through October 2022, a total of 16,416 infants were randomly assigned to azithromycin and 16,461 to placebo. Eighty-two infants in the azithromycin group and 75 infants in the placebo group died before 6 months of age (hazard ratio, 1.09; 95% confidence interval [CI], 0.80 to 1.49; P = 0.58); the absolute difference in mortality was 0.04 percentage points (95% CI, -0.10 to 0.21). There was no evidence of an effect of azithromycin on mortality in any of the prespecified subgroups, including subgroups defined according to age, sex, and baseline weight, and no evidence of a difference between the two trial groups in the incidence of adverse events.
Conclusions:
In this trial conducted in Burkina Faso, we found that administration of azithromycin to infants through the existing health care system did not prevent death. (Funded by the Bill and Melinda Gates Foundation; CHAT ClinicalTrials.gov number, NCT03676764.).
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