A Phase 4 interventional study of Azithromycin for Oral Suspension in Mortality and Antimicrobial Resistance, sponsored by University of California, San Francisco. Recruiting at 1 site in Niger. Open to participants aged 1 Month to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
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.
University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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CSI-level for mortality and AMR monitoring:
Individual level for mortality monitoring:
Individual-level for AMR monitoring:
Exclusion Criteria:
At the community-level:
At the individual-level:
Azithromycin distribution to children 1-59 months of age for four years using a door-to-door delivery approach via existing community health workers
Drug: 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
Drug: 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
Drug: Azithromycin for Oral Suspension
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.
Also known as: Zithromax
All-cause mortality
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
Time frame: 2 years
All-cause mortality
Under-5 mortality rate (U5MR, deaths per 1,000 live births) assessed by pregnancy history at 4 years, comparing the continue and stop arms
Time frame: 4 years
Prevalence of resistance to macrolides - nasopharyngeal swabs
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
Time frame: 2 years
Prevalence of resistance to macrolides - nasopharyngeal swabs
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
Time frame: 4 years
Load of genetic determinants of resistance to macrolides - rectal swabs
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
Time frame: 2 years
Load of genetic determinants of resistance to macrolides - rectal swabs
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
Time frame: 4 years
Number of clinic visits - infectious
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
Time frame: 2 years
Number of clinic visits - infectious
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
Time frame: 4 years
Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs
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
Time frame: 2 years
Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs
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
Time frame: 4 years
Program Cost Per Dose Delivered
Program costs will be tracked using routine expenditure reporting and micro-costing activities.
Time frame: 2 years
Prevalence of Reported Illness
Prevalence of caregiver reported illness among children 1-59 months of age in the program's catchment area in the 2 weeks following MDA as assessed through a household survey in a random subset of the population
Time frame: 2 years
Plan to share: Yes — De-identified data underlying outcomes publications will be made publicly available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be made available after publication of the outcomes and will be made available indefinitely.
Access criteria: Once made available, the data will be open access.
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Studies of the drug tested here: Azithromycin
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