Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso: The CHAT Randomized Clinical Trial.

Autor:	Oldenburg CE; Francis I. Proctor Foundation, University of California, San Francisco.; Department of Epidemiology & Biostatistics, University of California, San Francisco.; Department of Ophthalmology, University of California, San Francisco.; Institute for Global Health Sciences, University of California, San Francisco., Ouattara M; Centre de Recherche en Santé de Nouna, Burkina Faso., Bountogo M; Centre de Recherche en Santé de Nouna, Burkina Faso., Boudo V; Centre de Recherche en Santé de Nouna, Burkina Faso., Ouedraogo T; Centre de Recherche en Santé de Nouna, Burkina Faso., Compaoré G; Centre de Recherche en Santé de Nouna, Burkina Faso., Dah C; Centre de Recherche en Santé de Nouna, Burkina Faso., Zakane A; Centre de Recherche en Santé de Nouna, Burkina Faso., Coulibaly B; Centre de Recherche en Santé de Nouna, Burkina Faso., Bagagnan C; Centre de Recherche en Santé de Nouna, Burkina Faso., Hu H; Francis I. Proctor Foundation, University of California, San Francisco., O'Brien KS; Francis I. Proctor Foundation, University of California, San Francisco.; Department of Epidemiology & Biostatistics, University of California, San Francisco., Nyatigo F; Francis I. Proctor Foundation, University of California, San Francisco., Keenan JD; Francis I. Proctor Foundation, University of California, San Francisco.; Department of Ophthalmology, University of California, San Francisco., Doan T; Francis I. Proctor Foundation, University of California, San Francisco.; Department of Ophthalmology, University of California, San Francisco., Porco TC; Francis I. Proctor Foundation, University of California, San Francisco.; Department of Epidemiology & Biostatistics, University of California, San Francisco.; Department of Ophthalmology, University of California, San Francisco., Arnold BF; Francis I. Proctor Foundation, University of California, San Francisco.; Department of Ophthalmology, University of California, San Francisco., Lebas E; Francis I. Proctor Foundation, University of California, San Francisco., Sié A; Centre de Recherche en Santé de Nouna, Burkina Faso., Lietman TM; Francis I. Proctor Foundation, University of California, San Francisco.; Department of Epidemiology & Biostatistics, University of California, San Francisco.; Department of Ophthalmology, University of California, San Francisco.; Institute for Global Health Sciences, University of California, San Francisco.
Jazyk:	angličtina
Zdroj:	JAMA [JAMA] 2024 Feb 13; Vol. 331 (6), pp. 482-490.
DOI:	10.1001/jama.2023.27393
Abstrakt:	Importance: Repeated 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. Objective: To evaluate the efficacy of twice-yearly azithromycin to reduce mortality in children in the presence of seasonal malaria chemoprevention. Design, Setting, and Participants: This 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. Interventions: Communities 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 Measures: The primary outcome was all-cause childhood mortality, measured during a twice-yearly enumerative census. Results: A 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 Relevance: Mortality 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 Registration: ClinicalTrials.gov Identifier: NCT03676764.
Databáze:	MEDLINE
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