Sheila K West1, Evan Bloch2, Jerusha Weaver1, Beatriz Munoz1, Zakayo Mrango3, Mabula Kasubi4, Thomas Lietman5, Christian Coles6. 1. Dana Center for Preventive Ophthalmology, Maryland. 2. Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland. 3. National Institute for Medical Research, Kilosa District, Tanzania. 4. Department of Microbiology, Muhimbili Medical Center, Dar es Salaam, Tanzania. 5. Proctor Foundation, University of California, San Francisco. 6. Preventive Medicine and Biostatistics, Uniformed Services University, Bethesda, Maryland.
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.
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.
Authors: Evan M Bloch; Beatriz Munoz; Jerusha Weaver; Zakayo Mrango; Thomas M Lietman; Sheila K West Journal: Am J Trop Med Hyg Date: 2020-09 Impact factor: 2.345