Morbidity in a Longitudinal Cohort of Children Residing in Villages Randomized to Biannual Treatment With Azithromycin Versus Placebo.

ABSTRACT

BACKGROUND: The mechanisms underlying the finding of reduced child mortality in communities with biannual treatment with azithromycin remain unclear. We determined if there was a difference in morbidity in a cohort of children aged 1-36 months, residing in communities randomized to biannual treatment of preschool-aged children with azithromycin or placebo. METHODS: Thirty villages in Kilosa, Tanzania, were randomly assigned to receive biannual treatment of all children aged 1-59 months with either azithromycin (20/mg/kg single dose) or placebo. Children who were aged 1-36 months and participated in the baseline survey were enrolled in this cohort study and followed prospectively for 2 years. Children were monitored every 6 months for signs and symptoms of diarrheal disease, acute respiratory illness, and anemia. Mixed-effects models that include age, time, treatment arm, and the interaction of treatment arm and time as independent predictors were used to evaluate differences between children by treatment assignment over time. RESULTS: There was no difference in rates of diarrhea, fever, or anemia by treatment arm at baseline and at all phases of follow-up. The decline over time in reported cough was statistically significant in the children residing in the azithromycin communities, but not in the placebo communities. Once adjusting for clustering and age, the difference in decline between the 2 treatment arms was not significant (P = .09). CONCLUSIONS: A beneficial effect of azithromycin treatment on morbidity outcomes was not evident at biannual surveys. CLINICAL TRIALS REGISTRATION NCT02048007.