A double-masked placebo-controlled trial of azithromycin to prevent child mortality in Burkina Faso, West Africa: Community Health with Azithromycin Trial (CHAT) study protocol.

Autor: Sié A; Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso., Ouattara M; Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso., Bountogo M; Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso., Bagagnan C; Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso., Coulibaly B; Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso., Boudo V; Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso., Lebas E; Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA., Brogdon JM; Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA., Lin Y; Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA., Bärnighausen T; Heidelberg Institute of Global Health (HIGH), Heidelberg, Germany.; Africa Health Research Institute (AHRI), Somkhele, South Africa.; Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA., Porco TC; Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.; Department of Ophthalmology, University of California, San Francisco, CA, USA.; Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA., Doan T; Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.; Department of Ophthalmology, University of California, San Francisco, CA, USA., Lietman TM; Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA.; Department of Ophthalmology, University of California, San Francisco, CA, USA.; Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA., Oldenburg CE; Francis I. Proctor Foundation, University of California, 513 Parnassus Ave, Room S334, San Francisco, CA, USA. catherine.oldenburg@ucsf.edu.; Department of Ophthalmology, University of California, San Francisco, CA, USA. catherine.oldenburg@ucsf.edu.; Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA. catherine.oldenburg@ucsf.edu.
Jazyk: angličtina
Zdroj: Trials [Trials] 2019 Dec 04; Vol. 20 (1), pp. 675. Date of Electronic Publication: 2019 Dec 04.
DOI: 10.1186/s13063-019-3855-9
Abstrakt: Background: Biannual, mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. Subgroup analysis suggested that the strongest effects were in the youngest children, leading to the hypothesis that targeting younger age groups might be an effective strategy to prevent mortality. We present the methods of two randomized controlled trials designed to evaluate mass and targeted azithromycin distribution for the prevention of child mortality in Burkina Faso, West Africa.
Methods/design: The Child Health with Azithromycin Treatment (CHAT) study consists of two nested, randomized controlled trials. In the first, communities are randomized in a 1:1 fashion to biannual, mass azithromycin distribution or placebo. The primary outcome is under-5 all-cause mortality measured at the community level. In the second, children attending primary healthcare facilities during the first 5-12 weeks of life for a healthy child visit (e.g., for vaccination) are randomized in a 1:1 fashion to a single orally administered dose of azithromycin or placebo. The primary outcome is all-cause mortality measured at 6 months of age. The trial commenced enrollment in August 2019.
Discussion: This study is expected to provide evidence on two health systems delivery approaches (mass and targeted treatment) for azithromycin to prevent all-cause child mortality. The results will inform global and national policies related to azithromycin for the prevention of child mortality.
Trial Registration: ClinicalTrials.gov, ID: NCT03676764. Registered on 19 September 2018; prospectively registered pre results.
Databáze: MEDLINE
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