CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 252 enrolled
Drug / intervention
Azithromycin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03187834
NCT03187834Phase 4Completed

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

University of California, San Francisco·interventional·Posted Jun 15, 2017·Updated Mar 2, 2023

In Brief

A Phase 4 clinical trial evaluating Azithromycin, Amoxicillin, and 2 other interventions for Child Development. Completed, enrolled 252 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBurkina Faso, United States

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 15, 2017
Enrollment StartJul 4, 2017
Primary CompletionSep 1, 2017
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.0 years ago

Interventions

Azithromycindrug

Children in this arm will receive Azithromycin once a day.

Amoxicillindrug

Children in this arm will receive Amoxicillin twice a day.

Cotrimoxazoledrug

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

Placebodrug

Children in this arm will receive Placebo once a day.