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Effect Modification by Baseline Mortality in the MORDOR Azithromycin Trial

2019; American Society of Tropical Medicine and Hygiene; Volume: 103; Issue: 3 Linguagem: Inglês

10.4269/ajtmh.18-1004

1476-1645

Assaf P. Oron, Roy Burstein, Laina D. Mercer, Ahmed M. Arzika, Khumbo Kalua, Zakayo Mrango, Sheila K. West, Robin L. Bailey, Travis C. Porco, Thomas M. Lietman,

Health Systems, Economic Evaluations, Quality of Life

We examined whether baseline mortality risk, as a function of child age and site, modified the azithromycin mortality-reduction effect in the Macrolide Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) clinical trial. We used the Cox proportional hazards model with an interaction term. Three models were examined representing three sources for the baseline-risk covariate: two using sources external to MORDOR and the third leveraging data within MORDOR. All three models provided moderate evidence for the effect becoming stronger with increasing baseline mortality ( P = 0.02, 0.02, and 0.07, respectively) at the rate of approximately 6–12% additional mortality reduction per doubling of baseline mortality. Etiological and programmatic implications of these findings are discussed.