Clinical trial Recruiting at 14 sites Observational Ages 3 Months to 3

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

Official title: 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

Run by Centre Hospitalier Intercommunal Creteil · NCT03825874 · Data updated 2026-11-12

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.

More Urinary Tract Infections trials

Quick facts

Study typeObservational
Ages3 Months to 3 Years
SexAll
Enrollment200 (estimated)
SponsorCentre Hospitalier Intercommunal Creteil
Academic / other
Locations20 sites (Charenton-le-Pont and 19 other locations)
StatusRecruiting
StartedJanuary 19, 2019
Main results expectedJuly 2026
Study endsJuly 2026
Registry record updatedAugust 27, 2025
Trial IDNCT03825874 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Cabinet du Dr Benali
    Charenton-le-Pont, France
    Recruiting
  • Cabinet du Dr Coicadan
    Chennevières-sur-Marne, France
    Recruiting
  • Cabinet du Dr Corrard
    Combs-la-Ville, France
    Recruiting
  • Cabinet du Dr Thollot
    Essey-lès-Nancy, France
    Recruiting
  • Cabinet du Dr Deberdt
    Nogent-sur-Marne, France
    Recruiting
  • Cabinet du Dr Wollner
    Nogent-sur-Marne, France
    Recruiting
Show 14 more locations
  • Cabinet du Dr Romain
    Paris, France
    Recruiting
  • Cabinet du Dr Turberg-Romain
    Paris, France
    Recruiting
  • Cabinet du Dr Michot
    Paris, France
    Recruiting
  • Hospital Robert-Debré
    Paris, France
    Recruiting
  • Cabinet du Dr Cohen
    Saint-Maur-des-Fossés, France
    Recruiting
  • Cabinet du Dr Werner
    Villeneuve-lès-Avignon, France
    Recruiting
  • CHI Villeneuve-Saint-Georges
    Villeneuve-Saint-Georges, France
    Recruiting
  • Jean Verdier Hospital
    Bondy, Île-de-France Region, France
    Recruiting
  • CHU Le Kremlin-Bicêtre
    Le Kremlin-Bicêtre, France
    Not yet recruiting
  • 157 Avenue du Général Leclerc
    Maisons-Alfort, France
    Not yet recruiting
  • Centre Hospitalier de Meaux
    Meaux, France
    Not yet recruiting
  • 13 Villa Beauséjour
    Vincennes, France
    Not yet recruiting
  • Antoine Beclère Hospital
    Clamart, Île-de-France Region, France
    Not yet recruiting
  • André Mignot Hospital
    Le Chesnay, Île-de-France Region, France
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.