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Mortality Reduction After Oral Azithromycin: Morbidity Study

NCT02048007 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72000

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

  • Childhood Mortality

Interventions

DRUG

Azithromycin

Biannual mass oral azithromycin to children

DRUG

Placebo

Biannual mass oral placebo to children

Sponsors & Collaborators

Principal Investigators

  • Tom M Lietman, MD · University of California, San Francisco

  • Elodie J Lebas, RN · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2020-08-27
Completion
2020-08-27
FDA Drug
Yes

Countries

  • United States
  • Malawi
  • Niger
  • Tanzania
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02048007 on ClinicalTrials.gov