Keenan JD, et al. - Authors presumed that mass distribution of a broad-spectrum antibiotic agent to preschool children would reduce mortality in areas of sub-Saharan Africa that are currently far from meeting the Sustainable Development Goals of the United Nations. In postneonatal, preschool children in sub-Saharan Africa, compared to those assigned to placebo, childhood mortality was lower in communities randomly assigned to mass distribution of azithromycin with the largest effect seen in Niger. Experts noted a requirement of any implementation of a policy of mass distribution to strongly consider the potential impact of such a strategy on antibiotic resistance.

Methods

• Experts, in this cluster-randomized trial assigned communities in Malawi, Niger, and Tanzania to 4 twice-yearly mass distributions of either oral azithromycin (approximately 20 mg per kilogram of body weight) or placebo.
• They identified the children 1 to 59 months of age in twice-yearly censuses and offered participation in the trial.
• They determined vital status at subsequent censuses.
• Aggregate all-cause mortality was the primary outcome; country-specific rates were assessed in prespecified subgroup analyses.

Results

• As per data, a total of 1,533 communities underwent randomization, 190,238 children were identified in the census at baseline, and 323,302 person-years were monitored.
• Findings suggested the mean (±SD) azithromycin and placebo coverage over the 4 twice-yearly distributions to be 90.4±10.4%.
• Results suggested that the overall annual mortality rate was 14.6 deaths per 1000 person-years in communities that received azithromycin (9.1 in Malawi, 22.5 in Niger, and 5.4 in Tanzania) and 16.5 deaths per 1000 person-years in communities that received placebo (9.6 in Malawi, 27.5 in Niger, and 5.5 in Tanzania).
• Researchers noted that in communities that received azithromycin, mortality was 13.5% lower overall (95% confidence interval [CI], 6.7 to 19.8) vs in communities that received placebo (P<0.001); the rate was 5.7% lower in Malawi (95% CI, -9.7 to 18.9), 18.1% lower in Niger (95% CI, 10.0 to 25.5), and 3.4% lower in Tanzania (95% CI, -21.2 to 23.0).
• Children in the age group of 1 to 5 months had the greatest effect from azithromycin (24.9% lower mortality than that with placebo; 95% CI, 10.6 to 37.0).
• Serious adverse events occurring within a week after administration of the trial drug or placebo were uncommon, and the rate did not differ significantly between the groups.
• Evaluation of selection for antibiotic resistance is ongoing.