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Childhood Mortality | Mortality Reduction After Oral Azithromycin: Mortality Study

Childhood Mortality research study

What is the primary objective of this study?

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 is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Childhood Mortality

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AzithromycinChildren aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years

Drug:PlaceboChildren aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Biannual mass oral azithromycinComparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo. Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years

Biannual mass oral placeboComparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo. Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

Study Status

Completed

Start Date: December 2014

Completed Date: December 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: All-cause Mortality Rate in children aged 1-60 months

Secondary Outcome: Cause-specific Mortality Rate in children aged 1-60 months, as assessed from verbal autopsy

Study sponsors, principal investigator, and references

Principal Investigator: Tom M Lietman, MD

Lead Sponsor: University of California, San Francisco

Collaborator: Bill and Melinda Gates Foundation

More information:https://clinicaltrials.gov/show/NCT02047981

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