Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Nov;37(11):1082-1086.
doi: 10.1097/INF.0000000000001992.

Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of the PRET Cluster-randomized Trial in Niger

Affiliations
Randomized Controlled Trial

Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of the PRET Cluster-randomized Trial in Niger

Kieran S O'Brien et al. Pediatr Infect Dis J. 2018 Nov.

Abstract

Background: Mass distributions of azithromycin for trachoma have been associated with secondary benefits, including reductions in child mortality.

Methods: In the Partnership for the Rapid Elimination of Trachoma cluster-randomized trial in Niger, 24 communities were randomized to annual treatment of everyone and 24 communities were randomized to biannual treatment of children under 12 for 3 years (clinicaltrials.gov, NCT00792922). Treatment was a single dose of directly observed oral azithromycin (20 mg/kg up to 1 g in adults). Vital status was assessed during annual census and monitoring visits. In this prespecified secondary analysis, we compared the mortality rate among children 6 months to less than 5 years of age by treatment arm using negative binomial regression.

Results: Among children 6 months to less than 5 years of age, 404 deaths occurred during the study period. The mortality rate was 35.6 deaths per 1000 person-years (231 deaths, 95% CI: 30.9-40.9) in the annual arm and 29.0 deaths per 1000 person-years (173 deaths, 95% CI: 24.8-33.8) in the biannual arm. The mortality rate ratio comparing children in the biannual arm to the annual arm was 0.81 (95% CI: 0.66-1.00, P = 0.07; primary outcome). The mortality rate ratio comparing children who died from infectious causes in the biannual arm to the annual arm was 0.73 (95% CI: 0.57-0.94; P = 0.02). No adverse events were reported.

Conclusions: This secondary analysis of a cluster-randomized trial found a nonsignificant 19% decrease in mortality among children 6 months to less than 5 years of age who received biannual azithromycin compared with children who received annual azithromycin. This study was conducted in a high mortality, trachoma-endemic area; thus, results may be specific to this environment only. In addition, the trial was neither designed nor powered to detect a mortality effect, and we cannot rule out the possibility that mortality differences resulted from bias.

PubMed Disclaimer

Conflict of interest statement

DECLARATION OF INTERESTS

No conflicts of interest exist and none of the authors have any disclosures.

Figures

FIGURE 1
FIGURE 1
1CONSORT, Consolidated Standards of Reporting Trials.

Similar articles

Cited by

References

    1. Evans JR, Solomon AW. Antibiotics for trachoma. Cochrane Database Syst Rev. 2011 Cd001860. - PubMed
    1. Coles CL, Levens J, Seidman JC, Mkocha H, Munoz B, West S. Mass distribution of azithromycin for trachoma control is associated with short-term reduction in risk of acute lower respiratory infection in young children. Pediatr Infect Dis J. 2012;31:341–346. - PubMed
    1. Coles CL, Seidman JC, Levens J, Mkocha H, Munoz B, West S. Association of mass treatment with azithromycin in trachoma-endemic communities with short-term reduced risk of diarrhea in young children. Am J Trop Med Hyg. 2011;85:691–696. - PMC - PubMed
    1. Fry AM, Jha HC, Lietman TM, et al. Adverse and beneficial secondary effects of mass treatment with azithromycin to eliminate blindness due to trachoma in Nepal. Clin Infect Dis. 2002;35:395–402. - PubMed
    1. Schachterle SE, Mtove G, Levens JP, et al. Short-term malaria reduction by single-dose azithromycin during mass drug administration for trachoma, Tanzania. Emerg Infect Dis. 2014;20:941–949. - PMC - PubMed

Publication types

Associated data