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NCT Number: NCT06358872

Azithromycin for Child Survival in Niger II

Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years.

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Key information

Conditions

Mortality Antimicrobial Resistance

Age range

1 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

AVENIR II is a cluster-randomized adaptive platform trial designed to evaluate community health interventions in Niger. The initial focus is to monitor under-5 mortality and antimicrobial resistance as the azithromycin MDA for child survival program expands in Niger, with the following specific aims:

  • Mortality.
  • To conduct surveillance of mortality over time compared to the Sustainable Development Goal targets for under-5 mortality reduction. As this intervention is not intended to continue indefinitely, surveillance against a target is needed to determine when to stop.
  • To continue to evaluate the effectiveness of azithromycin MDA to reduce under-5 mortality. Given the risk of AMR, the effectiveness of the intervention over time is needed to fully weigh the risks against the benefits.
  • Antimicrobial Resistance. To determine the impact of azithromycin MDA on AMR in population- and clinic-based samples.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

CSI-level for mortality and AMR monitoring:

  • Located in a region participating in the program
  • Designated as rural by local study team
  • Selected for participation in monitoring activities
  • Safe and accessible for study teams
  • Verbal approval from community leaders

Individual level for mortality monitoring:

  • Residing in the catchment area of an eligible CSI
  • Selected for participation in monitoring activities
  • Female
  • Age between 12 and 55 years old
  • Verbal approval from participant

Individual-level for AMR monitoring:

  • Residing in the catchment area of an eligible CSI
  • Selected for participation in monitoring activities
  • Age between 1 and 59 months old
  • Verbal approval from a caregiver or guardian

Exclusion criteria

At the community-level:

  • Designated as urban by local study team
  • Inaccessible or unsafe for study team

At the individual-level:

  • Known allergy to macrolides

Treatment and study plan

Azithromycin for Oral Suspension

Drug

Azithromycin will be administered as a single dose, in oral suspension form for children. The dose will be calculated by age or height depending on the child's age Both dosing cups and syringes will be used to administer treatment. For children too young to drink out of a dosing cup, a 1 ml or 5 ml syringe will be used, and the calculated dose will be rounded upwards to the nearest 0.2 ml.

Other names: Zithromax

Primary outcomes

  1. All-cause mortality

    Time frame: 2 years

    Under-5 mortality rate (U5MR, deaths per 1,000 live births) assessed by pregnancy history at 2 years from the first treatment distribution, comparing the intervention and delayed arms

  2. All-cause mortality

    Time frame: 4 years

    Under-5 mortality rate (U5MR, deaths per 1,000 live births) assessed by pregnancy history at 4 years, comparing the continue and stop arms

  3. Prevalence of resistance to macrolides - nasopharyngeal swabs

    Time frame: 2 years

    Prevalence of macrolide-resistant pneumococcus from nasopharyngeal swabs in children 1-59 months old after 2 years of distributions, comparing the intervention and delayed arms

  4. Prevalence of resistance to macrolides - nasopharyngeal swabs

    Time frame: 4 years

    Prevalence of macrolide-resistant pneumococcus from nasopharyngeal swabs in children 1-59 months old after 4 years of distributions, comparing the continue and stop arms

  5. Load of genetic determinants of resistance to macrolides - rectal swabs

    Time frame: 2 years

    Load of genetic determinants of resistance to macrolides from rectal swabs in children 1-59 months old after 2 years of distributions, comparing the intervention and delayed arms

  6. Load of genetic determinants of resistance to macrolides - rectal swabs

    Time frame: 4 years

    Load of genetic determinants of resistance to macrolides from rectal swabs in children 1-59 months old after 4 years of distributions, comparing the continue and stop arms

Secondary outcomes

  1. Number of clinic visits - infectious

    Time frame: 2 years

    All infectious clinic visits among children 1-59 months of age in the program catchment area during the distribution period as assessed through passive surveillance of CSI records

  2. Number of clinic visits - infectious

    Time frame: 4 years

    All infectious clinic visits among children 1-59 months of age in the program catchment area during the distribution period as assessed through passive surveillance of CSI records

  3. Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs

    Time frame: 2 years

    Prevalence of genetic determinants of resistance from nasopharyngeal swabs in children 1-59 months old after 2 years of distributions, comparing the intervention and delayed arms

  4. Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs

    Time frame: 4 years

    Prevalence of genetic determinants of resistance from nasopharyngeal swabs in children 1-59 months old after 4 years of distributions, comparing the continue and stop arms

  5. Program Cost Per Dose Delivered

    Time frame: 2 years

    Program costs will be tracked using routine expenditure reporting and micro-costing activities.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea R Picariello, MPH

CONTACT

[email protected]

609-865-4532

Elodie Lebas

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Centre de Recherche Médicale et Sanitaire
  • Centre de recherche et interventions en santé publique (CRISP)
  • Le Programme National de Santé Oculaire
  • Ministère de la Santé Publique du Niger

Registry information

Official study title

Azithromycine Pour la Vie Des Enfants au Niger II

Acronym: AVENIR II

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 11, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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