CompletedPhase 4

Mortality Reduction After Oral Azithromycin: Mortality Study

United States, Malawi, Niger190,238 participantsStarted 2014-12

Plain-language summary

Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood mortality. We propose a single multi-site (multi-country), cluster-randomized trial comparing communities randomized to oral azithromycin with those randomized to placebo. We hypothesize that mass azithromycin treatments will reduce childhood mortality.

Who can participate

Age range1 Month – 60 Months

SexALL

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

Inclusion Criteria: Communities * The community location in target district. * The community leader consents to participation in the trial * The community's estimated population is between 200-2,000 people. * The community is not in an urban area. Individuals - All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census. Exclusion Criteria: Individuals \- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

What they're measuring

All-cause Mortality Rate in Children Aged 1-60 Months

Timeframe: 24 Months

All-cause Mortality Rate in Children Aged 1-60 Months

Timeframe: 36 months

Trial details

NCT IDNCT02047981

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09

Results submitted2019-08-29

View on ClinicalTrials.gov More Childhood Mortality trials