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Age-based targeting of biannual azithromycin distribution for child survival in Niger: an adaptive cluster-randomized trial protocol (AVENIR).

  • Author(s): O'Brien, Kieran S
  • Arzika, Ahmed M
  • Amza, Abdou
  • Maliki, Ramatou
  • Ousmane, Sani
  • Kadri, Boubacar
  • Nassirou, Beido
  • Mankara, Alio Karamba
  • Harouna, Abdoul Naser
  • Colby, Emily
  • Lebas, Elodie
  • Liu, Zijun
  • Le, Victoria
  • Nguyen, William
  • Keenan, Jeremy D
  • Oldenburg, Catherine E
  • Porco, Travis C
  • Doan, Thuy
  • Arnold, Benjamin F
  • Lietman, Thomas M
  • AVENIR Study Group
  • et al.

Published Web Location

https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-10824-7
No data is associated with this publication.
Abstract

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 ).

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