Actively Recruiting

Age: 3Months - 3Years
All Genders
NCT03825874

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

Led by Centre Hospitalier Intercommunal Creteil · Updated on 2025-08-27

200

Participants Needed

20

Research Sites

388 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is a major public health problem. It leads more frequent prescription of penems with the risk of emergence and spread of strains producing carbapenemases, which may be resistant to all known antibiotics. A policy of savings of penems is desirable. Among the alternatives to penems, amikacin is in the foreground. It remains active on the majority of E-ESBL strains. Some risk factors for E-ESBL emergence are known: recent antibiotic therapy (particularly quinolones and cephalosporins third generation), previous hospitalization or residence in a high endemic country. In pediatrics, E-ESBLs are primarily responsible for urinary tract infection. In France, E-ESBLs represent about 10% of the strains responsible for urinary tract infections. The Pathology Group Pediatric Infectious (GPIP) of the French Society of Pediatrics (SFP) and the Society of Infectious Pathology French Language (SPILF) have proposed different therapeutic options to treat febrile UTIs in children: amikacin intravenous; intravenous (IV) ceftriaxone or intramuscular (IM); or cefixime per-os (PO). The objective of this study is to compare the emergence of E-ESBLs in stools of children after febrile UTIs treatment with amikacin IV versus ceftriaxone or cefixime.

CONDITIONS

Official Title

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

Who Can Participate

Age: 3Months - 3Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant and child aged 3 months to under 3 years
  • Treated for febrile urinary tract infection with monotherapy of intravenous amikacin, intravenous or intramuscular ceftriaxone, or oral cefixime
  • Parents have read and understood the study information and provided consent
  • Patient is affiliated with a social security scheme
Not Eligible

You will not qualify if you...

  • Child treated with more than one antibiotic
  • Antibiotic treatment ongoing or stopped within the previous 7 days
  • Child is hospitalized
  • Refusal of consent by one of the parents

AI-Screening

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Trial Site Locations

Total: 20 locations

1

Cabinet du Dr Benali

Charenton-le-Pont, France, 94220

Actively Recruiting

2

Cabinet du Dr Coicadan

Chennevières-sur-Marne, France, 94430

Actively Recruiting

3

Cabinet du Dr Corrard

Combs-la-Ville, France, 77380

Actively Recruiting

4

Cabinet du Dr Thollot

Essey-lès-Nancy, France, 54270

Actively Recruiting

5

CHU Le Kremlin-Bicêtre

Le Kremlin-Bicêtre, France

Not Yet Recruiting

6

157 Avenue du Général Leclerc

Maisons-Alfort, France, 94700

Not Yet Recruiting

7

Centre Hospitalier de Meaux

Meaux, France

Not Yet Recruiting

8

Cabinet du Dr Deberdt

Nogent-sur-Marne, France, 94130

Actively Recruiting

9

Cabinet du Dr Wollner

Nogent-sur-Marne, France, 94130

Actively Recruiting

10

Cabinet du Dr Romain

Paris, France, 75015

Actively Recruiting

11

Cabinet du Dr Turberg-Romain

Paris, France, 75015

Actively Recruiting

12

Cabinet du Dr Michot

Paris, France, 75016

Actively Recruiting

13

Hospital Robert-Debré

Paris, France

Actively Recruiting

14

Cabinet du Dr Cohen

Saint-Maur-des-Fossés, France, 94100

Actively Recruiting

15

Cabinet du Dr Werner

Villeneuve-lès-Avignon, France, 30400

Actively Recruiting

16

CHI Villeneuve-Saint-Georges

Villeneuve-Saint-Georges, France, 94195

Actively Recruiting

17

13 Villa Beauséjour

Vincennes, France, 94300

Not Yet Recruiting

18

Jean Verdier Hospital

Bondy, Île-de-France Region, France

Actively Recruiting

19

Antoine Beclère Hospital

Clamart, Île-de-France Region, France

Not Yet Recruiting

20

André Mignot Hospital

Le Chesnay, Île-de-France Region, France

Not Yet Recruiting

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Research Team

F

Fouad Madhi, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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