CompletedPhase 4

Azithromycin for Child Survival in Niger: Mortality and Resistance Trial

Niger864,493 participantsStarted 2020-11-24

Plain-language summary

The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings.Targeting treatment to children 1-11 months old could reduce antimicrobial resistance by limiting antibiotic distributions while treating children at the highest mortality risk. However, this targeted intervention has not yet been tested. The AVENIR mortality/resistance trial aims to assess the efficacy of age-based targeting of biannual azithromycin distribution on mortality as well as determine the impact of age-based targeting on antimicrobial resistance.

Who can participate

Age range

1 Month – 59 Months

Sex

ALL

See this in plain English?

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

Exclusion criteria

. Population-based sample collections

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All-cause Mortality (1-59 Months Old)

Timeframe: from 6 months up to 2.5 years

All-cause Mortality (1-11 Months Old)

Timeframe: from 6 months up to 2.5 years

All-cause Mortality (12-59 Months Old)

Timeframe: from 6 months up to 2.5 years

Prevalence of Resistance to Macrolides - Nasopharyngeal Swabs (1-59 Months Old)

Timeframe: After 4 distributions (approximately 24 months)

Load of Genetic Determinants of Resistance to Macrolides - Rectal Swabs (1-59 Months Old)

Timeframe: After 4 distributions (approximately 24 months)

Trial details

NCT IDNCT04224987

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

Results submitted2025-02-03

View on ClinicalTrials.gov More Mortality trials

Plain-language summary

What they're measuring

All-cause Mortality (1-59 Months Old)

Timeframe: from 6 months up to 2.5 years

All-cause Mortality (1-11 Months Old)

Timeframe: from 6 months up to 2.5 years

All-cause Mortality (12-59 Months Old)

Timeframe: from 6 months up to 2.5 years

Prevalence of Resistance to Macrolides - Nasopharyngeal Swabs (1-59 Months Old)

Timeframe: After 4 distributions (approximately 24 months)

Load of Genetic Determinants of Resistance to Macrolides - Rectal Swabs (1-59 Months Old)

Timeframe: After 4 distributions (approximately 24 months)