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Azithromycin to Reduce Mortality - An Adaptive Cluster-Randomized Trial
Kieran S O'Brien1, Ahmed M Arzika1, Abdou Amza1
1From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (K.S.O., C.E.O., B.F.A., T.M.L.), University of California, San Francisco, San Francisco; and Centre de Recherche et Interventions en Santé Publique, Birni N'Gaoure (A.M.A., R.M., B.A., I.M.B., D.B., N.G., N.H., A.M.K., S.M., M.A.), and Programme Nationale de Santé Oculaire, Niamey (A.A., A.I.) - both in Niger.
Insights
Mass azithromycin distribution to children aged 1-59 months significantly reduced childhood mortality in sub-Saharan Africa. This approach proved more effective than limiting treatment to infants, highlighting a crucial public health strategy.
Area of Science:
- Global Health
- Infectious Diseases
- Pediatrics
Background:
- Twice-yearly mass azithromycin distribution is a potential intervention for reducing childhood mortality in sub-Saharan Africa.
- The World Health Organization recommended limiting distribution to infants (1-11 months) to mitigate antimicrobial resistance, a strategy not yet empirically tested.
Purpose of the Study:
- To evaluate the effectiveness of mass azithromycin distribution to children aged 1-59 months compared to infants aged 1-11 months for reducing childhood mortality.
- To assess the impact of different azithromycin distribution strategies on mortality rates in rural Niger.
Main Methods:
- A randomized controlled trial involving 1273 communities in Niger over 2 years.
- Communities were assigned to receive azithromycin for all children (1-59 months), only infants (1-11 months), or placebo.
- Mortality was monitored by census workers unaware of group assignments.
Main Results:
- Mass azithromycin distribution to children 1-59 months resulted in a 14% reduction in mortality compared to placebo (11.9 vs. 13.9 deaths per 1000 person-years; P<0.001).
- Distribution to infants 1-11 months showed a non-significant 6% reduction in mortality compared to placebo (22.3 vs. 23.9 deaths per 1000 person-years).
- Five serious adverse events were reported across all groups.
Conclusions:
- Mass azithromycin distribution to children aged 1-59 months significantly reduces mortality and is more effective than targeting only infants.
- Continued monitoring for antimicrobial resistance is essential.
- The study provides evidence supporting broader azithromycin distribution for child survival in sub-Saharan Africa.
Background:
Twice-yearly mass distribution of azithromycin to children is a promising intervention to reduce childhood mortality in sub-Saharan Africa. The World Health Organization recommended restricting distribution to infants 1 to 11 months of age to mitigate antimicrobial resistance, although this more limited treatment had not yet been tested.
Methods:
We randomly assigned rural communities in Niger to four twice-yearly distributions of azithromycin for children 1 to 59 months of age (child azithromycin group), four twice-yearly distributions of azithromycin for infants 1 to 11 months of age and placebo for children 12 to 59 months of age (infant azithromycin group), or placebo for children 1 to 59 months of age. Census workers who were not aware of the group assignments monitored mortality twice yearly over the course of 2 years. We assessed three primary community-level mortality outcomes (deaths per 1000 person-years), each examining a different age group and pairwise group comparison.
Results:
A total of 1273 communities were randomly assigned to the child azithromycin group (1229 were included in the analysis), 773 to the infant azithromycin group (751 included in the analysis), and 954 to the placebo group (929 included in the analysis). Among 382,586 children, 419,440 person-years and 5503 deaths were recorded. Lower mortality among children 1 to 59 months of age was observed in the child azithromycin group (11.9 deaths per 1000 person-years; 95% confidence interval [CI], 11.3 to 12.6) than in the placebo group (13.9 deaths per 1000 person-years; 95% CI, 13.0 to 14.8) (representing 14% lower mortality with azithromycin; 95% CI, 7 to 22; P<0.001). Mortality among infants 1 to 11 months of age was not significantly lower in the infant azithromycin group (22.3 deaths per 1000 person-years; 95% CI, 20.0 to 24.7) than in the placebo group (23.9 deaths per 1000 person-years; 95% CI, 21.6 to 26.2) (representing 6% lower mortality with azithromycin; 95% CI, -8 to 19). Five serious adverse events were reported: three in the placebo group, one in the infant azithromycin group, and one in the child azithromycin group.
Conclusions:
Azithromycin distributions to children 1 to 59 months of age significantly reduced mortality and was more effective than treatment of infants 1 to 11 months of age. Antimicrobial resistance must be monitored. (Funded by the Bill and Melinda Gates Foundation; AVENIR ClinicalTrials.gov number, NCT04224987.).
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