RecruitingPhase 4

Azithromycin for Child Survival in Niger II

Niger3,300,000 participantsStarted 2024-04-29

Plain-language 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.

Who can participate

Age range1 Month – 59 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

All-cause mortality

Timeframe: 2 years

All-cause mortality

Timeframe: 4 years

Prevalence of resistance to macrolides - nasopharyngeal swabs

Timeframe: 2 years

Prevalence of resistance to macrolides - nasopharyngeal swabs

Timeframe: 4 years

Load of genetic determinants of resistance to macrolides - rectal swabs

Timeframe: 2 years

Load of genetic determinants of resistance to macrolides - rectal swabs

Timeframe: 4 years

Trial details

NCT IDNCT06358872

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04-29

Contact for this trial

Andrea R Picariello, MPH

609-865-4532 andrea.picariello@ucsf.edu

View on ClinicalTrials.gov More Mortality trials

Plain-language summary

Who can participate

Age range1 Month – 59 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

All-cause mortality

Timeframe: 2 years

All-cause mortality

Timeframe: 4 years

Prevalence of resistance to macrolides - nasopharyngeal swabs

Timeframe: 2 years

Prevalence of resistance to macrolides - nasopharyngeal swabs

Timeframe: 4 years

Load of genetic determinants of resistance to macrolides - rectal swabs

Timeframe: 2 years

Load of genetic determinants of resistance to macrolides - rectal swabs

Timeframe: 4 years