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

Last updated: August 26, 2025
Sponsor: Centre Hospitalier Intercommunal Creteil
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Tract Infections

Treatment

usual antibiotic treatment

Amikacin

Clinical Study ID

NCT03825874
MIKA
2017-A02372-51
  • Ages 3-3
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 wascollected

  • Patient affiliated to a social security scheme (Social Security or Universal MedicalCoverage)

Exclusion

Exclusion Criteria:

  • Child treated with more than one antibiotic (eg treatment with dual therapyceftriaxone / cefotaxime and aminoglycoside)

  • Antibiotherapy in progress or discontinued in the previous 7 days

  • Hospitalized child

  • Refusal of one of the parents

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: usual antibiotic treatment
Phase:
Study Start date:
January 19, 2019
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Antoine Beclère Hospital

    Clamart, Ile-de France
    France

    Site Not Available

  • Jean Verdier Hospital

    Bondy, Ile-de-France
    France

    Active - Recruiting

  • André Mignot Hospital

    Le Chesnay, Ile-de-France
    France

    Site Not Available

  • Jean Verdier Hospital

    Bondy 3031815, Île-de-France Region 3012874
    France

    Active - Recruiting

  • Antoine Beclère Hospital

    Clamart 3024783, Île-de-France Region 3012874
    France

    Site Not Available

  • André Mignot Hospital

    Le Chesnay 3004630, Île-de-France Region 3012874
    France

    Site Not Available

  • Cabinet du Dr Vie Le Sage

    Aix-les-Bains, 73100
    France

    Site Not Available

  • Cabinet du Dr De Pontual

    Bondy, 93160
    France

    Site Not Available

  • Cabinet du Dr Belaroussi

    Boulogne, 92100
    France

    Site Not Available

  • Hopital Ambroise Paré

    Boulogne-Billancourt,
    France

    Site Not Available

  • Hôpital Saint Camille

    Bry-sur-Marne, 94360
    France

    Site Not Available

  • Cabinet du Dr Derkx

    Champigny-sur-Marne, 94500
    France

    Site Not Available

  • Cabinet du Dr Benali

    Charenton-le-Pont, 94220
    France

    Site Not Available

  • Cabinet du Dr Benali

    Charenton-le-Pont 3026637, 94220
    France

    Active - Recruiting

  • Cabinet du Dr Coicadan

    Chennevières-sur-Marne, 94430
    France

    Site Not Available

  • Cabinet du Dr Coicadan

    Chennevières-sur-Marne 3025509, 94430
    France

    Active - Recruiting

  • Cabinet du Dr Broussin

    Châtillon, 92320
    France

    Site Not Available

  • Cabinet du Dr Corrard

    Combs-la-Ville, 77380
    France

    Site Not Available

  • Cabinet du Dr Corrard

    Combs-la-Ville 3024107, 77380
    France

    Active - Recruiting

  • Cabinet du Dr Donikian-Pujol

    Crolles, 38920
    France

    Site Not Available

  • CHI Créteil

    Créteil, 94000
    France

    Site Not Available

  • Cabinet du Dr Thollot

    Essey-lès-Nancy, 54270
    France

    Site Not Available

  • Cabinet du Dr Thollot

    Essey-lès-Nancy 3019607, 54270
    France

    Active - Recruiting

  • CHU Le Havre

    Le Havre,
    France

    Site Not Available

  • CHU Le Kremlin-Bicêtre

    Le Kremlin-Bicêtre,
    France

    Site Not Available

  • CHU Le Kremlin-Bicêtre

    Le Kremlin-Bicêtre 3003737,
    France

    Site Not Available

  • Roger Salengro Hospital

    Lille,
    France

    Site Not Available

  • Centre Hospitalier Général de Longjumeau

    Longjumeau,
    France

    Site Not Available

  • CHU Lyon

    Lyon,
    France

    Site Not Available

  • 157 Avenue du Général Leclerc

    Maisons-Alfort, 94700
    France

    Site Not Available

  • 157 Avenue du Général Leclerc

    Maisons-Alfort 2996568, 94700
    France

    Site Not Available

  • Cabinet du Dr Defives

    Marquette-lez-Lille, 59520
    France

    Site Not Available

  • Centre Hospitalier de Meaux

    Meaux,
    France

    Site Not Available

  • Centre Hospitalier de Meaux

    Meaux 2994798,
    France

    Site Not Available

  • Cabinet du Dr Bodin

    Montgeron, 91230
    France

    Site Not Available

  • CHU Lenval

    Nice,
    France

    Site Not Available

  • Cabinet du Dr Deberdt

    Nogent-sur-Marne, 94130
    France

    Active - Recruiting

  • Cabinet du Dr Wollner

    Nogent-sur-Marne, 94130
    France

    Site Not Available

  • Cabinet du Dr Deberdt

    Nogent-sur-Marne 2990265, 94130
    France

    Active - Recruiting

  • Cabinet du Dr Wollner

    Nogent-sur-Marne 2990265, 94130
    France

    Active - Recruiting

  • Centre Hospitalier d'Orsay

    Orsay,
    France

    Site Not Available

  • Cabinet du Dr Michot

    Paris, 75016
    France

    Active - Recruiting

  • Cabinet du Dr Romain

    Paris, 75015
    France

    Active - Recruiting

  • Cabinet du Dr Turberg-Romain

    Paris, 75015
    France

    Active - Recruiting

  • Hospital Robert-Debré

    Paris,
    France

    Site Not Available

  • Cabinet du Dr Michot

    Paris 2988507, 75016
    France

    Active - Recruiting

  • Cabinet du Dr Romain

    Paris 2988507, 75015
    France

    Active - Recruiting

  • Cabinet du Dr Turberg-Romain

    Paris 2988507, 75015
    France

    Active - Recruiting

  • Hospital Robert-Debré

    Paris 2988507,
    France

    Active - Recruiting

  • CHU Rouen

    Rouen,
    France

    Site Not Available

  • Cabinet du Dr Cohen

    Saint-Maur-des-Fossés, 94100
    France

    Site Not Available

  • Cabinet du Dr Cohen

    Saint-Maur-des-Fossés 2978179, 94100
    France

    Active - Recruiting

  • Cabinet du Dr Bakhache

    Saint-Quentin, 02100
    France

    Site Not Available

  • Cabinet du Dr Nave

    Sélestat, 67600
    France

    Site Not Available

  • CHI Villeneuve-Saint-Georges

    Villeneuve-Saint-Georges, 94195
    France

    Site Not Available

  • CHI Villeneuve-Saint-Georges

    Villeneuve-Saint-Georges 2968529, 94195
    France

    Active - Recruiting

  • Cabinet du Dr Werner

    Villeneuve-lès-Avignon, 30400
    France

    Site Not Available

  • Cabinet du Dr Werner

    Villeneuve-lès-Avignon 2968545, 30400
    France

    Active - Recruiting

  • 13 Villa Beauséjour

    Vincennes, 94300
    France

    Site Not Available

  • 13 Villa Beauséjour

    Vincennes 2968054, 94300
    France

    Site Not Available

  • Clinique de l'Essonne

    Évry, 91000
    France

    Site Not Available

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