Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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