Community Health Azithromycin Trial in Burkina Faso

Summary

An estimated 7.7 million pre-school aged children die each year, the majority from infectious diseases. Mass azithromycin distributions for trachoma may have the unintended benefit of reducing childhood mortality. We recently demonstrated the biannual mass azithromycin distribution significantly reduces all-cause child mortality in a cluster randomized trial (MORDOR I) conducted in three diverse regions of Sub-Saharan Africa. Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood morbidity and mortality. We propose a cluster randomized trial designed to repeat the original study to confirm the original results in a different geographic study with similarly high child mortality, and to better understand the mechanism behind any effect of azithromycin on child mortality. We hypothesize that biannual mass azithromycin distribution will reduce child mortality compared to placebo, and that this effect will be primarily driven by a reduction in infectious burden. Objectives: 1. Determine the efficacy of biannual mass azithromycin distribution versus placebo in children aged 1-59 months for reduction in all-cause mortality. 2. Determine the efficacy of targeted azithromycin distribution to infants during an early infant healthcare visit (approximately 5th through 12th week of life) on infant mortality. 3. Determine the mechanism behind the effect of biannual mass azithromycin distribution for reduction in child mortality. The study will be conducted in the Nouna District in northwestern Burkina Faso.

Timeline

Start

2019-08-01

Primary completion

2023-12-01

Completion

2023-12-01

Publications

• Gebreegziabher EA, Sie A, Ouattara M, Bountogo M, Coulibaly B, Boudo V, Ouedraogo T, Lebas E, Hu H, Ante-Testard PA, Gregorich SE, O'Brien KS, Hsiang MS, Glidden DV, Arnold BF, Lietman TM, Oldenburg CE. Exploring heterogeneity in treatment effects: The impact and interaction of asset-based wealth and mass azithromycin distribution on child mortality. PLoS One. 2026 Feb 9;21(2):e0341665. doi: 10.1371/journal.pone.0341665. eCollection 2026.
• Oldenburg CE, Coulibaly B, Sie A, Ouattara M, Bountogo M, Compaore G, Kiemde D, Compaore A, Zonou G, Hinterwirth A, Zhong L, Chen C, Liu Y, Yu D, Abraham T, Lebas E, Hu H, Hilde-Jones M, Arnold BF, Doan T, Lietman TM. Macrolide and non-macrolide resistance after 36 months of mass azithromycin distribution in Burkina Faso: A cluster randomized trial. Clin Infect Dis. 2026 Jan 31:ciag051. doi: 10.1093/cid/ciag051. Online ahead of print.
• Bountogo M, Ouattara M, Dah C, Coulibaly B, Ouedraogo T, Zakane A, Boudo V, Lebas E, Hu H, Arnold BF, Lietman TM, Sie A, Oldenburg CE. Azithromycin for infants at risk of poor growth and development: A pooled secondary analysis of two randomized controlled trials. PLoS One. 2025 Aug 8;20(8):e0328208. doi: 10.1371/journal.pone.0328208. eCollection 2025.
• Gebreegziabher EA, Sie A, Ouattara M, Bountogo M, Coulibaly B, Boudo V, Ouedraogo T, Lebas E, Hu H, Ante-Testard PA, Gregorich SE, O'Brien KS, Hsiang MS, Glidden DV, Arnold BF, Lietman TM, Oldenburg CE. Exploring Heterogeneity in Treatment Effects: The Impact and Interaction of Asset-Based Wealth and Mass Azithromycin Distribution on Child Mortality. medRxiv [Preprint]. 2025 Jul 6:2025.07.05.25329685. doi: 10.1101/2025.07.05.25329685.
• Gebreegziabher EA, Ouattara M, Bountogo M, Coulibaly B, Boudo V, Ouedraogo T, Lebas E, Hu H, O'Brien KS, Hsiang MS, Glidden DV, Arnold BF, Lietman TM, Sie A, Oldenburg CE. The role of Seasonal Malaria Chemoprevention in the effect of Azithromycin on Child Mortality: A Secondary Analysis of the CHAT Cluster Randomized Clinical Trial. medRxiv [Preprint]. 2025 May 2:2025.04.30.25326740. doi: 10.1101/2025.04.30.25326740.
• Sie A, Ouattara M, Bountogo M, Boudo V, Ouedraogo T, Dah C, Compaore G, Lebas E, Hu H, Porco TC, Arnold BF, O'Brien KS, Lietman TM, Oldenburg CE. Mass azithromycin for prevention of child mortality among children with acute malnutrition: A subgroup analysis of a cluster randomized controlled trial. PLOS Glob Public Health. 2024 Oct 28;4(10):e0003875. doi: 10.1371/journal.pgph.0003875. eCollection 2024.
• Oldenburg CE, Ouattara M, Bountogo M, Boudo V, Ouedraogo T, Compaore G, Dah C, Zakane A, Coulibaly B, Bagagnan C, Hu H, O'Brien KS, Nyatigo F, Keenan JD, Doan T, Porco TC, Arnold BF, Lebas E, Sie A, Lietman TM. Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso: The CHAT Randomized Clinical Trial. JAMA. 2024 Feb 13;331(6):482-490. doi: 10.1001/jama.2023.27393.
• Sie A, Ouattara M, Bountogo M, Dah C, Ouedraogo T, Boudo V, Lebas E, Hu H, Arnold BF, O'Brien KS, Lietman TM, Oldenburg CE. Single-dose azithromycin for infant growth in Burkina Faso: Prespecified secondary anthropometric outcomes from a randomized controlled trial. PLoS Med. 2024 Jan 23;21(1):e1004345. doi: 10.1371/journal.pmed.1004345. eCollection 2024 Jan.
• Sie A, Ouattara M, Bountogo M, Boudo V, Ouedraogo T, Compaore G, Dah C, Bagagnan C, Lebas E, Hu H, Rice J, Porco TC, Arnold BF, Lietman TM, Oldenburg CE. Azithromycin during Routine Well-Infant Visits to Prevent Death. N Engl J Med. 2024 Jan 18;390(3):221-229. doi: 10.1056/NEJMoa2309495.
• Sie A, Ouattara M, Bountogo M, Bagagnan C, Coulibaly B, Boudo V, Lebas E, Brogdon JM, Lin Y, Barnighausen T, Porco TC, Doan T, Lietman TM, Oldenburg CE; Etude CHAT Study Group. 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. Trials. 2019 Dec 4;20(1):675. doi: 10.1186/s13063-019-3855-9.

Drugs

Indications

No indication recorded.