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NCT03187834 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 4
Development phase
252
Enrollment target

NCT03187834: Completed Phase 4 study, sponsored by University of California, San Francisco.

NCT03187834 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 252 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03187834, a Phase 4 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 4
Development phase
252 participants
Enrollment target

Study 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.

Primary Outcome

The primary outcome of the study was pre-specified as α-diversity (inverse Simpson's) at the genus level, expressed in effective number. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales.

Interventions

  • DRUG Placebo
  • DRUG Azithromycin
  • DRUG Amoxicillin
  • DRUG Cotrimoxazole

Trial Details

FieldValue
Enrollment Target 252 participants
Start Date 2017-07-04
Est. Completion 2019-09-01
Phase Phase 4

What the finished NCT03187834 record still lists

NCT03187834 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (51% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT03187834 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03187834 about?

NCT03187834 is a clinical study titled "Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso". 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...

What is the current status of trial NCT03187834?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 252 participants. The study started on 2017-07-04. Estimated completion is 2019-09-01.

What interventions are being tested in trial NCT03187834?

The interventions under investigation include: Placebo (DRUG), Azithromycin (DRUG), Amoxicillin (DRUG), Cotrimoxazole (DRUG).

Who is sponsoring clinical trial NCT03187834?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03187834's enrollment target sits among peer trials

252 339th of 2000 higher than 1,659 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03187834, the US trial registry maintained by the National Library of Medicine. NCT03187834 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.