NCT03187834

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Accepted

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.

Detailed description

This study is designed to better understand the effect of a short course of antibiotics on changes in intestinal and nasopharyngeal microbiome on treated children and untreated household contacts. The investigators hypothesize that a short course of antibiotics will lead to decreased bacterial diversity shortly after completion of the antibiotic course, and higher probability of identification of bacterial resistance genes in rectal and nasopharyngeal samples. The investigators hypothesize that a 5-day course of antibiotics (azithromycin, amoxicillin, or co-trimoxazole) will lead to significantly decreased intestinal and nasopharyngeal bacterial diversity among children aged 6-59 months. Specific Aim 1. Determine the effect of treatment with antibiotics on microbiome diversity in children aged 6-59 months following a 5-day course of antibiotics. Specific Aim 1A. Determine the direct effect of a 5-day course of azithromycin, amoxicillin, or co-trimoxazole on intestinal and nasopharyngeal bacterial diversity in children aged 6-59 months compared to no treatment. Specific Aim 1B. Determine the indirect effect of antibiotic treatment of children in a household on intestinal and nasopharyngeal bacterial diversity in an untreated child aged 6-59 months. Specific Aim 1C. Assess the association between intestinal bacterial diversity and anthropometry in a population-based sample of children.

Conditions

• Child Development

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-04
• Primary completion: 2017-09-01
• Completion: 2019-09-01
• First posted: 2017-06-15
• Last updated: 2023-03-02
• Results posted: 2023-03-02

Locations

2 sites across 2 countries: United States, Burkina Faso

Regulatory

• FDA-regulated drug study