Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
NCT ID: NCT03825874
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2019-01-19
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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amikacin IV
Febrile urinary tract infection treated with amikacin IV
Amikacin
A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.
Other antibiotics
Febrile urinary tract infection treated with other antibiotic, according to the recommendations: ceftriaxone or cefixime
usual antibiotic treatment
A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.
Interventions
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Amikacin
A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.
usual antibiotic treatment
A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.
Eligibility Criteria
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Inclusion Criteria
* 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
* Antibiotherapy in progress or discontinued in the previous 7 days
* Hospitalized child
* Refusal of one of the parents
3 Months
3 Years
ALL
No
Sponsors
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Centre Hospitalier Intercommunal Creteil
OTHER
Responsible Party
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Principal Investigators
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Fouad MADHI, MD
Role: PRINCIPAL_INVESTIGATOR
CHI Créteil
Locations
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Cabinet du Dr Benali
Charenton-le-Pont, , France
Cabinet du Dr Coicadan
Chennevières-sur-Marne, , France
Cabinet du Dr Corrard
Combs-la-Ville, , France
Cabinet du Dr Thollot
Essey-lès-Nancy, , France
CHU Le Kremlin-Bicêtre
Le Kremlin-Bicêtre, , France
157 Avenue du Général Leclerc
Maisons-Alfort, , France
Centre Hospitalier de Meaux
Meaux, , France
Cabinet du Dr Deberdt
Nogent-sur-Marne, , France
Cabinet du Dr Wollner
Nogent-sur-Marne, , France
Cabinet du Dr Romain
Paris, , France
Cabinet du Dr Turberg-Romain
Paris, , France
Cabinet du Dr Michot
Paris, , France
Hospital Robert-Debré
Paris, , France
Cabinet du Dr Cohen
Saint-Maur-des-Fossés, , France
Cabinet du Dr Werner
Villeneuve-lès-Avignon, , France
CHI Villeneuve-Saint-Georges
Villeneuve-Saint-Georges, , France
13 Villa Beauséjour
Vincennes, , France
Jean Verdier Hospital
Bondy, Île-de-France Region, France
Antoine Beclère Hospital
Clamart, Île-de-France Region, France
André Mignot Hospital
Le Chesnay, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Hadj Benali
Role: primary
Lucette Coicadan
Role: primary
François Corrard
Role: primary
Franck Thollot
Role: primary
Annie ELBEZ
Role: primary
Patrice Deberdt
Role: primary
Alain Wollner
Role: primary
Olivier Romain
Role: primary
Catherine Turberg-Romain
Role: primary
Anne-Sylvestre Michot
Role: primary
Alexis Rybak
Role: primary
Robert Cohen
Role: primary
Andreas Werner
Role: primary
Aurélie GARRAFFO
Role: primary
Christophe BATARD
Role: primary
Other Identifiers
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2017-A02372-51
Identifier Type: OTHER
Identifier Source: secondary_id
MIKA
Identifier Type: -
Identifier Source: org_study_id
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