Azithromycin for Child Survival in Niger II
- Conditions
- MortalityAntimicrobial Resistance
- Interventions
- Registration Number
- NCT06358872
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3300000
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stop Distribution Azithromycin for Oral Suspension 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 Continuous Distribution Azithromycin for Oral Suspension Azithromycin distribution to children 1-59 months of age for four years using a door-to-door delivery approach via existing community health workers Delayed Distribution Azithromycin for Oral Suspension 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
- Primary Outcome Measures
Name Time Method Load of genetic determinants of resistance to macrolides - rectal swabs 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
All-cause mortality 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
Prevalence of resistance to macrolides - nasopharyngeal swabs 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
- Secondary Outcome Measures
Name Time Method Number of clinic visits - infectious 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
Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs 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
Program Cost Per Dose Delivered 2 years Program costs will be tracked using routine expenditure reporting and micro-costing activities.
Trial Locations
- Locations (1)
Program National de Santé Oculaire
🇳🇪Niamey, Niger