RecruitingNCT03825874

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

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


Sponsor

Centre Hospitalier Intercommunal Creteil

Enrollment

200 participants

Start Date

Jan 19, 2019

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 3 MonthsMax Age: 3 Years

Inclusion Criteria4

  • 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 was collected
  • Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage)

Exclusion Criteria4

  • Child treated with more than one antibiotic (eg treatment with dual therapy ceftriaxone / cefotaxime and aminoglycoside)
  • Antibiotherapy in progress or discontinued in the previous 7 days
  • Hospitalized child
  • Refusal of one of the parents

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Interventions

OTHERAmikacin

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.

OTHERusual 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.


Locations(20)

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

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NCT03825874


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