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Mortality Reduction After Oral Azithromycin: Mortality Study

NCT02047981 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 190238

Last updated 2022-11-08

Study results available
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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.

Conditions

  • Childhood Mortality

Interventions

DRUG

Azithromycin

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

DRUG

Placebo

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

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
Max Age
60 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

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

Study Locations

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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 NCT02047981 on ClinicalTrials.gov