Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso

Abstract

ImportanceRepeated mass distribution of azithromycin has been shown to reduce childhood mortality by 14% in sub-Saharan Africa. However, the estimated effect varied by location, suggesting that the intervention may not be effective in different geographical areas, time periods, or conditions.ObjectiveTo evaluate the efficacy of twice-yearly azithromycin to reduce mortality in children in the presence of seasonal malaria chemoprevention.Design, Setting, and ParticipantsThis cluster randomized placebo-controlled trial evaluating the efficacy of single-dose azithromycin for prevention of all-cause childhood mortality included 341 communities in the Nouna district in rural northwestern Burkina Faso. Participants were children aged 1 to 59 months living in the study communities.InterventionsCommunities were randomized in a 1:1 ratio to receive oral azithromycin or placebo distribution. Children aged 1 to 59 months were offered single-dose treatment twice yearly for 3 years (6 distributions) from August 2019 to February 2023.Main Outcomes and MeasuresThe primary outcome was all-cause childhood mortality, measured during a twice-yearly enumerative census.ResultsA total of 34 399 children (mean [SD] age, 25.2 [18] months) in the azithromycin group and 33 847 children (mean [SD] age, 25.6 [18] months) in the placebo group were included. A mean (SD) of 90.1% (16.0%) of the censused children received the scheduled study drug in the azithromycin group and 89.8% (17.1%) received the scheduled study drug in the placebo group. In the azithromycin group, 498 deaths were recorded over 60 592 person-years (8.2 deaths/1000 person-years). In the placebo group, 588 deaths were recorded over 58 547 person-years (10.0 deaths/1000 person-years). The incidence rate ratio for mortality was 0.82 (95% CI, 0.67-1.02; P = .07) in the azithromycin group compared with the placebo group. The incidence rate ratio was 0.99 (95% CI, 0.72-1.36) in those aged 1 to 11 months, 0.92 (95% CI, 0.67-1.27) in those aged 12 to 23 months, and 0.73 (95% CI, 0.57-0.94) in those aged 24 to 59 months.Conclusions and RelevanceMortality in children (aged 1-59 months) was lower with biannual mass azithromycin distribution in a setting in which seasonal malaria chemoprevention was also being distributed, but the difference was not statistically significant. The study may have been underpowered to detect a clinically relevant difference.Trial RegistrationClinicalTrials.gov Identifier: NCT03676764

Trends in Uncomplicated and Severe Malaria following Seasonal Malaria Chemoprevention Administration in Nouna, Burkina Faso

“…15 CHAT methods have been fully described previously. 13,15 According to a previous study, the median rate of healthcare visits in the villages was 6.7 per 100 child-months with the most common reasons for visit being pneumonia (37.5%), malaria (25.1%) and diarrhea (9.1%) infections. 16 In this analysis, we included uncomplicated and severe malaria diagnoses in 2021 among children 1-59 months old reported from the health posts in the CHAT study area.…”

“…Using routine healthcare data for malaria diagnoses among children under 5 in Nouna, Burkina Faso from government-run primary healthcare facilities, census data from a cluster randomized trial of 278 villages in Burkina Faso 13 and SMC administration dates, we evaluated the short-term effects of SMC in the weeks following administration. The objective of this study was to describe uncomplicated and severe malaria incidence rates in 2021 overall and during the malaria season in the presence of SMC and to evaluate the effect of SMC by comparing malaria rates in the weeks after administration of SMC in Burkina Faso.…”