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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Age-based targeting of biannual azithromycin distribution for child survival in Niger: an adaptive cluster-randomized trial protocol (AVENIR)
BMC Public Health, Volume 21, No. 1, Article 822, Year 2021
Notification
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Description
Background: Biannual distribution of azithromycin to children 1–59 months old reduced mortality by 14% in a cluster-randomized trial. The World Health Organization has proposed targeting this intervention to the subgroup of children 1–11 months old to reduce selection for antimicrobial resistance. Here, we describe a trial designed to determine the impact of age-based targeting of biannual azithromycin on mortality and antimicrobial resistance. Methods: AVENIR is a cluster-randomized, placebo-controlled, double-masked, response-adaptive large simple trial in Niger. During the 2.5-year study period, 3350 communities are targeted for enrollment. In the first year, communities in the Dosso region will be randomized 1:1:1 to 1) azithromycin 1–11: biannual azithromycin to children 1–11 months old with placebo to children 12–59 months old, 2) azithromycin 1–59: biannual azithromycin to children 1–59 months old, or 3) placebo: biannual placebo to children 1–59 months old. Regions enrolled after the first year will be randomized with an updated allocation based on the probability of mortality in children 1–59 months in each arm during the preceding study period. A biannual door-to-door census will be conducted to enumerate the population, distribute azithromycin and placebo, and monitor vital status. Primary mortality outcomes are defined as all-cause mortality rate (deaths per 1000 person-years) after 2.5 years from the first enrollment in 1) children 1–59 months old comparing the azithromycin 1–59 and placebo arms, 2) children 1–11 months old comparing the azithromycin 1–11 and placebo arm, and 3) children 12–59 months in the azithromycin 1–11 and azithromycin 1–59 arms. In the Dosso region, 50 communities from each arm will be followed to monitor antimicrobial resistance. Primary resistance outcomes will be assessed after 2 years of distributions and include 1) prevalence of genetic determinants of macrolide resistance in nasopharyngeal samples from children 1–59 months old, and 2) load of genetic determinants of macrolide resistance in rectal samples from children 1–59 months old. Discussion: As high-mortality settings consider this intervention, the results of this trial will provide evidence to support programmatic and policy decision-making on age-based strategies for azithromycin distribution to promote child survival. Trial registration: This trial was registered on January 13, 2020 (clinicaltrials.gov: NCT04224987). © 2021, The Author(s).
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC8082631/bin/12889_2021_10824_MOESM1_ESM.doc
Authors & Co-Authors
O'Brien, Kieran S.
United States, San Francisco
University of California, San Francisco
Arzika, Ahmed M.
Niger, Niamey
Programme Nationale de Santé Oculaire
Amza, Abdou
Niger, Niamey
Programme Nationale de Santé Oculaire
Maliki, Ramatou
Niger, Niamey
Programme Nationale de Santé Oculaire
Ousmane, Sani
Niger, Niamey
Centre de Recherche Médicale et Sanitaire
Kadri, Boubacar
Niger, Niamey
Programme Nationale de Santé Oculaire
Nassirou, Beido
Niger, Niamey
Programme Nationale de Santé Oculaire
Mankara, Alio Karamba
Niger, Niamey
Programme Nationale de Santé Oculaire
Harouna, Abdoul Naser
Niger, Niamey
Programme Nationale de Santé Oculaire
Colby, Emily
United States, San Francisco
University of California, San Francisco
Lebas, Elodie
United States, San Francisco
University of California, San Francisco
Liu, Zijun
United States, San Francisco
University of California, San Francisco
Le, Victoria
United States, San Francisco
University of California, San Francisco
Nguyen, William
United States, San Francisco
University of California, San Francisco
Keenan, Jeremy David
United States, San Francisco
University of California, San Francisco
Oldenburg, Catherine Elizabeth
United States, San Francisco
University of California, San Francisco
Porco, Travis C.
United States, San Francisco
University of California, San Francisco
Doan, Thuy A.
United States, San Francisco
University of California, San Francisco
Arnold, Benjamin F.
United States, San Francisco
University of California, San Francisco
Lietman, Thomas M.
United States, San Francisco
University of California, San Francisco
de Borman, Nicolas
Belgium, Brussels
Bluesquare
Dresse, Stephane
Belgium, Brussels
Bluesquare
Olekhnovitch, Romain
Belgium, Brussels
Bluesquare
Lurton, Gregoire
Belgium, Brussels
Bluesquare
Monchy, Léa
Belgium, Brussels
Bluesquare
de Wulf, Martin
Belgium, Brussels
Bluesquare
Brander, Rebecca L.
Unknown Affiliation
Chao, Dennis L.
Unknown Affiliation
Heine, James
Unknown Affiliation
Izadnegahdar, Rasa
Unknown Affiliation
Lamberti, Laura M.
Unknown Affiliation
Oron, Assaf P.
Unknown Affiliation
Rajaram, Surabhi
Unknown Affiliation
Steele, Matthew
Unknown Affiliation
Seyfoule, Amina
Unknown Affiliation
Arzika, Ahmed Mamane
Niger, Niamey
Centre de Recherche et Interventions en Santé Publique
Bello, Fati
Niger, Niamey
Centre de Recherche et Interventions en Santé Publique
Boubacar, Diallo Alpha
Niger, Niamey
Centre de Recherche et Interventions en Santé Publique
Harouna, Amadou
Niger, Niamey
Centre de Recherche et Interventions en Santé Publique
Karamba, Alio
Niger, Niamey
Centre de Recherche et Interventions en Santé Publique
Nomao, Farissat
Niger, Niamey
Centre de Recherche et Interventions en Santé Publique
Omar, Abraham
Niger, Niamey
Centre de Recherche et Interventions en Santé Publique
Issa, Ibrahima
Niger, Niamey
Centre de Recherche Médicale et Sanitaire
Jambou, Ronan
Niger, Niamey
Centre de Recherche Médicale et Sanitaire
Labbo, Rabiou
Niger, Niamey
Centre de Recherche Médicale et Sanitaire
Lamine, S’ Hooshim N.
Niger, Niamey
Centre de Recherche Médicale et Sanitaire
Rakia, Boubakar
Niger, Niamey
Centre de Recherche Médicale et Sanitaire
Sadikou, Maikano
Niger, Niamey
Centre de Recherche Médicale et Sanitaire
Lindsay, Brianna
Unknown Affiliation
Kittur, Nupur
Unknown Affiliation
Roos, David
Unknown Affiliation
Tomko, Sheena Shah
Unknown Affiliation
Adji, Issa
Unknown Affiliation
Ali, Djibo
Unknown Affiliation
Alzouma, Souleymane
Unknown Affiliation
Boubacar, Maidanda
Unknown Affiliation
Boureima, Diegou
Unknown Affiliation
Daouda, Cheik Boureima
Unknown Affiliation
Djatao, Idi Moussa
Unknown Affiliation
Etienne, Ibrahim Jean
Unknown Affiliation
Maiga, El Hadji Boubakar H.
Unknown Affiliation
Oumarou, Amadou
Unknown Affiliation
Sakina, Ocquet
Unknown Affiliation
Samuila, Sanoussi
Unknown Affiliation
Addiss, David G.
United States, Atlanta
Emory University
Assao, Mourtala
Niger
Niger Ministry of Health
Hightower, Allen W.
United States, Madison
Cdc
Jackson, Brian
United States, Aurora
Children’s Hospital Colorado
Russell, Fiona Mary
Australia, Melbourne
University of Melbourne
Hocking, Frances
United States, New York
Global Health Strategies Llc
Mhirsi, Zied
United States, New York
Global Health Strategies Llc
Pawson, Dan
United States, New York
Global Health Strategies Llc
Amouzou, Agbessi
United States, Baltimore
Johns Hopkins University
Black, Robert E.
United States, Baltimore
Johns Hopkins University
Ahmed, Waqas
United States, New York
Pfizer Inc.
Hatajik, Todd D.
United States, New York
Pfizer Inc.
Jenson, Julie
United States, New York
Pfizer Inc.
Knirsch, Charles A.
United States, New York
Pfizer Inc.
Lin, Chiao Chin
United States, New York
Pfizer Inc.
Abdou, Amza
Niger, Niamey
Programme Nationale de Santé Oculaire
Beido, Nassirou
Niger, Niamey
Programme Nationale de Santé Oculaire
Maïdanda, Boubacar
Niger, Niamey
Programme Nationale de Santé Oculaire
Ba, Maelle
Unknown Affiliation
Diop, Yaye Sophiétou
Unknown Affiliation
Djibo, Yacine H.
Unknown Affiliation
Hutton, Gráinne
Unknown Affiliation
Ndiaye, Fara
Unknown Affiliation
Arnold, Benjamin F.
United States, San Francisco
University of California, San Francisco
Chen, Cindi
United States, San Francisco
University of California, San Francisco
Cook, Catherine A.
United States, San Francisco
University of California, San Francisco
Lietman, Thomas M.
United States, San Francisco
University of California, San Francisco
Ruder, Kevin
United States, San Francisco
University of California, San Francisco
Rutherford, George Williams
United States, San Francisco
University of California, San Francisco
Zhong, Lina
United States, San Francisco
University of California, San Francisco
Zhou, Zhaoxia
United States, San Francisco
University of California, San Francisco
Bertozzi, Stefano Michele
United States, Berkeley
University of California, Berkeley
Khan, Jim G.
United States, Berkeley
University of California, Berkeley
Marseille, Elliot A.
United States, Berkeley
University of California, Berkeley
Boo, Gianluca
United Kingdom, Southampton
University of Southampton
Darin, Edith
United Kingdom, Southampton
University of Southampton
Tatem, Andrew J.
United Kingdom, Southampton
University of Southampton
Statistics
Citations: 8
Authors: 101
Affiliations: 16
Identifiers
Doi:
10.1186/s12889-021-10824-7
ISSN:
14712458
Research Areas
Genetics And Genomics
Health System And Policy
Maternal And Child Health
Study Design
Randomised Control Trial
Cross Sectional Study
Study Locations
Niger