Mortality Reduction After Oral Azithromycin: Mortality Study

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Bill and Melinda Gates Foundation; Johns Hopkins University; London School of Hygiene and Tropical Medicine
• Treatments: Azithromycin

Criteria

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)