Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of The PRET Cluster-Randomized Trial in Niger.


O'Brien, KS; Cotter, SY; Amza, A; Kadri, B; Nassirou, B; Stoller, NE; Zhou, Z; West, SK; Bailey, RL; Keenan, JD; Porco, TC; Lietman, TM; (2018) Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of The PRET Cluster-Randomized Trial in Niger. The Pediatric infectious disease journal. ISSN 0891-3668 DOI: https://doi.org/10.1097/INF.0000000000001992

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Abstract

Mass distributions of azithromycin for trachoma have been associated with secondary benefits, including reductions in child mortality. In the PRET cluster-randomized trial for trachoma 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 (20mg/kg up to 1gm in adults). Vital status was assessed during annual census and monitoring visits. In this pre-specified 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. 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 to 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 to 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 to 0.94, P=0.02). No adverse events were reported. This secondary analysis of a cluster-randomized trial found a non-significant 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.

Item Type: Article
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
PubMed ID: 29561511
URI: http://researchonline.lshtm.ac.uk/id/eprint/4647136

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