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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Months to 3 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 20 sites (Charenton-le-Pont and 19 other locations) |
| Status | Recruiting |
| Started | January 19, 2019 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | August 27, 2025 |
| Trial ID | NCT03825874 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
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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
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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
- Principal investigator: Fouad MADHI, MD — CHI Créteil
- Study coordinator: Fouad Madhi, MD
- Email: fouad.madhi@chicreteil.fr
- Phone: +33157025422
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.