Mortality Reduction After Oral Azithromycin: Morbidity Study

• Status: Completed
• Trial end date: 2020-08-27
• Target enrollment: 0
• Participant gender: All

Summary

The long-term goal of this study is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood morbidity and increasing growth, and for the potential selection of antibiotic resistance. The investigators propose a set of 3 cluster-randomized trials in Malawi, Niger, and Tanzania comparing communities randomized to oral azithromycin with those randomized to placebo. To assess the generalizability of the intervention, investigators will monitor for antibiotic resistance, which could potentially limit adoption of mass antibiotic treatments. The investigators will also assess several measures of infectious diseases. The investigators hypothesize that mass azithromycin treatments will reduce childhood morbidity and will be accompanied by an acceptable level of antibiotic resistance.

• 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 (Intervention):

• Children-treated arms (all 3 sites): All children aged 1-60 months (up to but not including the 5th birthday), as assessed at the most recent biannual census

Individuals (Examination & Sample Collection):

• All swabs, blood tests, and stool samples: A random sample of children aged 1-60 months (up to but not including the 5th birthday) based on the previous census

• Anthropometric measurements: All children aged 1-60 months (up to but not including the 5th birthday) will have anthropometric measurements assessed.

• Nasopharyngeal swabs in untreated children: A random sample of individuals aged 7 - 12 years (7th birthday up to but not including the 12th birthday), as assessed from the previous census

• Clinic-based nasopharyngeal swabs: All children aged 1-60 months (up to but not including the 5th birthday) who present to a local health clinic in the study area and report symptoms of a respiratory infection

Exclusion Criteria:

Individuals:

• Pregnant women

• All those who are allergic to macrolides or azalides

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