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Longer-Term Assessment of Azithromycin for Reducing Childhood Mortality in Africa
Jeremy D Keenan1, Ahmed M Arzika1, Ramatou Maliki1
1From the Francis I. Proctor Foundation (J.D.K., C.C., E.L., Y.L., K.J.R., K.S.O., T.D., C.E.O., T.C.P., T.M.L.), the Departments of Ophthalmology (J.D.K., T.D., C.E.O., T.C.P., T.M.L.) and Epidemiology and Biostatistics (K.J.R., C.E.O., T.C.P., T.M.L.), and the Institute for Global Health Sciences (C.E.O., T.M.L.), University of California, San Francisco, San Francisco, and the University of California, Berkeley, School of Public Health, Berkeley (K.S.O.) - both in California; and the Carter Center (A.M.A., R.M., N.B., S.E.A., M.M.A., E.K.C.) and Emory University (P.M.E.), Atlanta, and the International Trachoma Initiative, Decatur (P.M.E.) - all in Georgia.
Background:
The MORDOR I trial (Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance) showed that in Niger, mass administration of azithromycin twice a year for 2 years resulted in 18% lower postneonatal childhood mortality than administration of placebo. Whether this benefit could increase with each administration or wane owing to antibiotic resistance was unknown.
Methods:
In the Niger component of the MORDOR I trial, we randomly assigned 594 communities to four twice-yearly distributions of either azithromycin or placebo to children 1 to 59 months of age. In MORDOR II, all these communities received two additional open-label azithromycin distributions. All-cause mortality was assessed twice yearly by census workers who were unaware of participants' original assignments.
Results:
In the MORDOR II trial, the mean (±SD) azithromycin coverage was 91.3±7.2% in the communities that received twice-yearly azithromycin for the first time (i.e., had received placebo for 2 years in MORDOR I) and 92.0±6.6% in communities that received azithromycin for the third year (i.e., had received azithromycin for 2 years in MORDOR I). In MORDOR II, mortality was 24.0 per 1000 person-years (95% confidence interval [CI], 22.1 to 26.3) in communities that had originally received placebo in the first year and 23.3 per 1000 person-years (95% CI, 21.4 to 25.5) in those that had originally received azithromycin in the first year, with no significant difference between groups (P = 0.55). In communities that had originally received placebo, mortality decreased by 13.3% (95% CI, 5.8 to 20.2) when the communities received azithromycin (P = 0.007). In communities that had originally received azithromycin and continued receiving it for an additional year, the difference in mortality between the third year and the first 2 years was not significant (-3.6%; 95% CI, -12.3 to 4.5; P = 0.50).
Conclusions:
We found no evidence that the effect of mass administration of azithromycin on childhood mortality in Niger waned in the third year of treatment. Childhood mortality decreased when communities that had originally received placebo received azithromycin. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT02047981.).
Insights
Mass azithromycin administration in Niger significantly reduced childhood mortality, with benefits sustained into the third year. This public health strategy shows promise for reducing child deaths and combating antibiotic resistance.
Area of Science:
- Global Health
- Infectious Diseases
- Pediatrics
Background:
- The MORDOR I trial demonstrated that mass azithromycin distribution in Niger reduced childhood mortality by 18% over two years.
- Uncertainty remained regarding the sustained efficacy of azithromycin and potential impacts of antibiotic resistance with continued use.
Purpose of the Study:
- To evaluate the long-term impact of mass azithromycin administration on childhood mortality in Niger.
- To assess whether the mortality reduction benefits observed in MORDOR I persisted or waned in a third year of treatment.
- To investigate potential effects of continued azithromycin use on antibiotic resistance patterns.
Main Methods:
- The MORDOR II trial extended the MORDOR I study, involving 594 communities in Niger.
- Communities received two additional open-label azithromycin distributions to children aged 1-59 months.
- All-cause mortality was monitored by census workers unaware of treatment assignments.
Main Results:
- Azithromycin coverage exceeded 91% in both new and previously treated communities during the third year.
- No significant difference in mortality rates was observed between communities initially receiving placebo versus azithromycin (24.0 vs. 23.3 per 1000 person-years).
- Communities switching from placebo to azithromycin experienced a significant 13.3% reduction in mortality.
- Communities continuously receiving azithromycin showed no significant change in mortality in the third year compared to the first two years (-3.6%).
Conclusions:
- Mass administration of azithromycin continued to effectively reduce childhood mortality in Niger into the third year of treatment.
- No evidence of waning benefits or significant impact of antibiotic resistance on mortality reduction was observed.
- The findings support the sustained public health benefit of mass azithromycin distribution for reducing childhood mortality in this setting.
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