Secondary Logo

Institutional members access full text with Ovid®

Share this article on:

Childhood Mortality After Mass Distribution of Azithromycin

A Secondary Analysis of the PRET Cluster-randomized Trial in Niger

O’Brien, Kieran S., MPH*; Cotter, Sun Y., MPH*; Amza, Abdou, MD; Kadri, Boubacar, MD; Nassirou, Beido, MS; Stoller, Nicole E., MPH*; Zhou, Zhaoxia, BA*; West, Sheila K., PhD; Bailey, Robin L., PhD§; Keenan, Jeremy D., MD*,¶; Porco, Travis C., PhD*,‖; Lietman, Thomas M., MD*,¶,‖

The Pediatric Infectious Disease Journal: November 2018 - Volume 37 - Issue 11 - p 1082–1086
doi: 10.1097/INF.0000000000001992
Original Studies

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.

From the *Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California

Programme FSS/Université Abdou Moumouni de Niamey, Programme National de Santé Oculaire, Niamey, Niger

Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, Marlyland

§Clinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom

Departments of Ophthalmology

Epidemiology & Biostatistics, University of California San Francisco, San Francisco, California.

Accepted for publication December 30, 2017.

This work was supported by the Bill and Melinda Gates Foundation (48027); National Institutes of Health (NIH/NEI K23 EYO19881-01, NIH/NCRR/OD UCSF-CTSI KL2 RR024130); Research to Prevent Blindness; That Man May See; and the Harper-Inglis Trust.

Funded by Bill and Melinda Gates Foundation (48027), National Institutes of Health (NIH/NEI K23 EYO19881-01, NIH/NCRR/OD UCSF-CTSI KL2 RR024130), Research to Prevent Blindness, That Man May See, Harper-Inglis Trust.

Trial registration: NCT00792922 (clinicaltrials.gov).

The authors have no conflicts of interest to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (www.pidj.com).

Address for correspondence: Thomas M. Lietman, MD, Francis I. Proctor Foundation, Department of Ophthalmology, University of California, San Francisco, 513 Parnassus, Med Sci 309A, San Francisco, CA 94143. E-mail: tom.lietman@ucsf.edu.

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.