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Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso

NCT03187834 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2023-03-02

Study results available
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Summary

The use of antibiotics has saved millions of human lives, however consumption of antibiotics can select for antibiotic resistant organisms and may lead to changes in commensal microbiome. This study is designed to estimate the effect of antibiotic consumption on microbiome in a rural region of rural Burkina Faso. Changes in the intestinal and nasopharyngeal microbiome and resistome following a short course of antibiotics will be measured.

Conditions

  • Child Development

Interventions

DRUG

Azithromycin

Children in this arm will receive Azithromycin once a day.

DRUG

Amoxicillin

Children in this arm will receive Amoxicillin twice a day.

DRUG

Cotrimoxazole

Children in this arm will receive co-trimoxazole once a day.

DRUG

Placebo

Children in this arm will receive Placebo once a day.

Sponsors & Collaborators

Principal Investigators

  • Thomas M Lietman, MD · UCSF F.I. Proctor Foundation

  • Catherine E Oldenburg, ScD · UCSF F.I. Proctor Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-04
Primary Completion
2017-09-01
Completion
2019-09-01
FDA Drug
Yes

Countries

  • United States
  • Burkina Faso

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 NCT03187834 on ClinicalTrials.gov