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Digestive tract effects after common antibiotics for urinary infections in young children

Comparison of the Impact on Digestive Portage of Broad Spectrum Beta-Lactamase-Producing Enterobacteriaceae (E-ESBLs) of Proposed Treatments in Outbreaks of Childhood Urinary Tract Infection

Observational Centre Hospitalier Intercommunal Creteil · NCT03825874

This project will see if common antibiotic treatments for febrile urinary tract infections in children under 3 change their gut bacteria or increase antibiotic-resistant strains.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages3 Months to 3 Years
SexAll
SponsorCentre Hospitalier Intercommunal Creteil Academic / other
Locations20 sites (Charenton-le-Pont and 19 other locations)
Trial IDNCT03825874 on ClinicalTrials.gov

What this trial studies

This observational project follows infants and young children (3 months to under 3 years) treated as outpatients with single-agent amikacin, ceftriaxone, or cefixime for febrile urinary tract infections. Stool samples and clinical data will be collected from children whose parents provide consent, excluding hospitalized children, those on multiple antibiotics, or recent antibiotic users. The team will compare changes in gut microbiota and the acquisition or persistence of extended‑spectrum beta‑lactamase (ESBL)–producing Enterobacteriaceae after each antibiotic approach. Results are intended to inform antibiotic choices that minimize selection for highly resistant strains.

Who should consider this trial

Good fit: Children aged 3 months to under 3 years treated as outpatients for febrile urinary tract infection with single‑agent amikacin, ceftriaxone, or cefixime whose parents consent and who are enrolled in the French social security system.

Not a fit: Hospitalized children, those treated with more than one antibiotic, children who received antibiotics in the previous seven days, or children whose parents do not consent are not eligible and would not benefit from participation.

Why it matters

Potential benefit: If successful, this could help identify antibiotic choices that better preserve children's gut microbiota and reduce the spread of multidrug‑resistant bacteria.

How similar studies have performed: Previous observational work has shown that different antibiotics can alter gut colonization with resistant Enterobacteriaceae, so the approach has supporting evidence though it is not entirely novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Infant and child (age ≥ 3 months and \<3 years)
* Patient treated for febrile urinary tract infection as monotherapy with amikacin IV, ceftriaxone (IV or IM) or cefixime PO \*
* Whose parents read and understood the newsletter and whose express consent was collected
* Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage)

Exclusion Criteria:

* Child treated with more than one antibiotic (eg treatment with dual therapy ceftriaxone / cefotaxime and aminoglycoside)
* Antibiotherapy in progress or discontinued in the previous 7 days
* Hospitalized child
* Refusal of one of the parents

Where this trial is running

Charenton-le-Pont and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urinary Tract InfectionsUrinary Tract Infections in Children
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.