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Summary

for people ages 1 month to 60 months (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:
Tom M Lietman

Description

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.

Official Title

Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Mortality Trial

Details

We will assess childhood mortality over two years, comparing communities where children aged 1-60 months receive biannual oral azithromycin ("Azithromycin" arm), to communities where the children receive biannual oral placebo ("Control" arm).

This is a cluster-randomized trial; at each site, communities within a contiguous area of 300,000 to 600,000 individuals will be randomized to azithromycin or placebo using simple random sampling.

Specific Aims

Specific Aim 1: To test the hypothesis that mass distributions of oral azithromycin targeted to 1-60 month old children reduces childhood mortality, in a cluster-randomized trial

Specific Aim 2: To assess the cost-effectiveness of mass azithromycin in reducing childhood mortality

Keywords

Childhood Mortality Azithromycin Mass treatment Infection Verbal Autopsy

Eligibility

You can join if…

Open to people ages 1 month to 60 months

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.

You CAN'T join if...

Individuals

  • Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

Locations

  • Johns Hopkins University in progress, not accepting new patients
    Baltimore, Maryland, 21205, United States
  • London School of Hygiene & Tropical Medicine in progress, not accepting new patients
    London, United Kingdom
  • The Carter Center, Niger accepting new patients
    Niamey, Niger
  • Kongwa Trachoma Project accepting new patients
    Kongwa, Tanzania
  • College of Medicine at the University of Malawi, Blantyre accepting new patients
    Blantyre, Malawi

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02047981
Phase
Phase 4
Lead Scientist
Tom M Lietman
Study Type
Interventional
Last Updated
July 1, 2017