Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
Condition: Child Development
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Azithromycin; Amoxicillin; Cotrimoxazole; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Children in this arm will receive Azithromycin once a day.; Children in this arm will receive Amoxicillin twice a day.; Children in this arm will receive co-trimoxazole once a day.; Children in this arm will receive Placebo once a day.
Other intervention name(s): Zithromax
Intervention MeSH terms: Amoxicillin; Azithromycin; Trimethoprim, Sulfamethoxazole Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infection; azithromycin; amoxicillin; co-trimoxazole; trachoma; mass treatment