Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of the PRET Cluster-randomized Trial in Niger. Issue 11 (November 2018)

• Record Type: Journal Article
• Authors: O'Brien, Kieran S.; Cotter, Sun Y.; Amza, Abdou; Kadri, Boubacar; Nassirou, Beido; Stoller, Nicole E.; Zhou, Zhaoxia; West, Sheila K.; Bailey, Robin L.; Keenan, Jeremy D.; Porco, Travis C.; Lietman, Thomas M.
• Is Part Of: Pediatric infectious disease journal. Volume 37:Issue 11(2018)
• Publication Date: 2018-11
• Subjects: azithromycin -- mortality -- mass drug administration -- cluster-randomized trial; Communicable diseases in children -- Periodicals; Infection in children -- Periodicals; 618.929
• DOI: 10.1097/INF.0000000000001992
• Languages: English
• ISSNs: 0891-3668

Abstract

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. Abstract : Supplemental Digital Content is available in the text.