Actively Recruiting

Age: 3Months - 3Years
All Genders
ID03825874

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

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

200

Participants Needed

20

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The trial investigates the impact of different antibiotic treatments on the digestive tract colonization by extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) in children with febrile urinary tract infections (UTIs). E-ESBL bacteria are a significant public health concern due to their resistance to many antibiotics. This research compares the emergence of E-ESBL strains in stools following treatment with either intravenous amikacin or other recommended antibiotics like ceftriaxone or cefixime in young children. Participants receive treatment for febrile UTIs with either amikacin given intravenously or with usual antibiotics such as intravenous or intramuscular ceftriaxone or oral cefixime. Before starting antibiotics, an anorectal swab is taken to check for E-ESBL colonization. A follow-up swab is performed three to four days after starting treatment to assess changes in bacterial presence. Children are monitored for the presence and type of E-ESBL bacteria in their stools four days after treatment begins. Researchers also track antibiotic resistance patterns, fever resolution, side effects related to antibiotic use, and the rate of UTI relapse over one and a half months. Participation involves stool sampling and clinical evaluations during the treatment period, with the study expected to complete by mid-2026.

CONDITIONS

Brief 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 or child aged 3 months or older and less than 3 years
  • Treated for febrile urinary tract infection with monotherapy using amikacin IV, ceftriaxone (IV or IM), or cefixime PO
  • Parents have read and understood the study information and given written consent
  • Patient is covered by a social security or universal medical coverage plan
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 4 days

Participants have anorectal swabs collected before starting antibiotic treatment and again 3 to 4 days after treatment begins to observe the presence and characteristics of antibiotic-resistant bacteria in stools.

2 visits (in-person)

Long-term Monitoring

Duration - 1.5 months

Participants are observed for side effects due to antibiotic therapy and for relapse of urinary tract infection.

1 follow-up visit (in-person)

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

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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