Azithromycin for Child Survival in Niger II (AVENIR II)

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 4

Conditions: Mortality; Antimicrobial Resistance

Treatments: Drug: Azithromycin for Oral Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT06358872

23-39839

Details and patient eligibility

About

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.

Full description

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:

1. Mortality.

   1. 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.
   2. 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.

2. Antimicrobial Resistance. To determine the impact of azithromycin MDA on AMR in population- and clinic-based samples.

Enrollment: 3,300,000 estimated patients

Sex: All

Ages: 1 to 59 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,300,000 participants in 3 patient groups

Continuous Distribution

Active Comparator group

Description:

Azithromycin distribution to children 1-59 months of age for four years using a door-to-door delivery approach via existing community health workers

Treatment:

Drug: Azithromycin for Oral Suspension

Delayed Distribution

Active Comparator group

Description:

Delayed, by two years, azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers

Treatment:

Drug: Azithromycin for Oral Suspension

Stop Distribution

Active Comparator group

Description:

Stopping azithromycin distribution after two years to children 1-59 months of age using a door-to-door delivery approach via existing community health workers

Treatment:

Drug: Azithromycin for Oral Suspension