Mortality Reduction After Oral Azithromycin: Morbidity Study

Completed · Phase 4 · Has a placebo group

Conditions studied: Childhood Mortality

In brief

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.

Key facts

Study ID

NCT02048007

Run by

University of California, San Francisco

People needed

72000

Starts

2014-11-01

Expected to finish

2020-08-27

Last updated by the study team

2021-03-17

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• UCSF Proctor Foundation — San Francisco, California, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• College of Medicine at the University of Malawi, Blantyre — Blantyre, Malawi
• The Carter Center, Niger — Niamey, Niger
• Kongwa Trachoma Project — Kongwa, Tanzania
• London School of Hygiene & Tropical Medicine — London, United Kingdom

Full record on ClinicalTrials.gov

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