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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-04

Study Completion Date

2019-09-01

Brief Summary

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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.

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Detailed Description

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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

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Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Households will be randomized to one of four treatment arms (azithromycin, cotrimoxazole, amoxicillin, or placebo), and each child age 6-59 months in the household will receive 5 days of treatment. One child within each of the antibiotic households will be randomly selected to receive placebo instead of the antibiotc, to allow for study of indirect effects of antibiotic use

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double blind

Study Groups

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Azithromycin

Comparison of nasopharyngeal and rectal microbiome in children receiving Azithromycin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm and treated for 5 days.

Children will receive treatment everyday, once a day as is:

Azithromycin: 10 mg/kg once daily on Day 1, then 5 mg/kg once daily Days 2-5

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

Children in this arm will receive Azithromycin once a day.

Amoxicillin

Comparison of nasopharyngeal and rectal microbiome in children receiving Amoxicillin versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.

Children will receive treatment everyday, twice a day as is:

Amoxicillin: 25 mg/kg/day, divided into twice daily doses for Days 1-5

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

Children in this arm will receive Amoxicillin twice a day.

Cotrimoxazole

Comparison of nasopharyngeal and rectal microbiome in children receiving Cotri-moxazole versus children receiving placebo Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.

Children will receive treatment everyday, once a day as is:

Co-trimoxazole: 240 mg daily for Days 1-5

Group Type ACTIVE_COMPARATOR

Cotrimoxazole

Intervention Type DRUG

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

Placebo

Comparison of nasopharyngeal and rectal microbiome in children receiving placebo versus children receiving antibiotics Children aged 6 months to 59 months will be measured and weighed then, they will be randomized to one of the study arm.

Children will receive Placebo everyday, once a day.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Children in this arm will receive Placebo once a day.

Interventions

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Azithromycin

Children in this arm will receive Azithromycin once a day.

Intervention Type DRUG

Amoxicillin

Children in this arm will receive Amoxicillin twice a day.

Intervention Type DRUG

Cotrimoxazole

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

Intervention Type DRUG

Placebo

Children in this arm will receive Placebo once a day.

Intervention Type DRUG

Other Intervention Names

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Zithromax

Eligibility Criteria

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Inclusion Criteria

* Households will be eligible for inclusion in the study if they have 2 or more children aged 6 months to 59 months currently residing in the household. Children from the household will be eligible if they are 6-59 months of age and are not currently receiving antibiotic treatment

Exclusion Criteria

* Children who are allergic to any of the study antibiotics will be excluded. Individuals aged under 6 months and 5 years or older will be excluded. Children already receiving antibiotics for an ongoing disease will be excluded.

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes