Clinical trial NCT03825874: Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Tract Infections
Urinary Tract Infections in Children
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child from 3 months to 3 years treated for febrile urinary tract infection

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Presence of E-BLSE in stools
timeFrame: day 4
Secondary outcomes:
measure: Type of E-BLSE strain in stools
timeFrame: day 4
measure: Rate of enzymatic resistance of E-BLSE strain in stools
timeFrame: 4 days
measure: Fever
timeFrame: 4 days
measure: side effects due to antibiotic therapy
timeFrame: at 1.5 months
measure: rate of relapse of urinary tract infection
timeFrame: 1.5 months
Other outcomes:
Locations:
city: Clamart
country: France
facility: Antoine Beclère Hospital
state: Ile-de France
city: Bondy
country: France
facility: Jean Verdier Hospital
state: Ile-de-France
city: Le Chesnay
country: France
facility: André Mignot Hospital
state: Ile-de-France
city: Charenton-le-Pont
country: France
facility: Cabinet du Dr Benali
city: Chennevières-sur-Marne
country: France
facility: Cabinet du Dr Coicadan
city: Combs-la-Ville
country: France
facility: Cabinet du Dr Corrard
city: Essey-lès-Nancy
country: France
facility: Cabinet du Dr Thollot
city: Le Kremlin-Bicêtre
country: France
facility: CHU Le Kremlin-Bicêtre
city: Maisons-Alfort
country: France
facility: 157 Avenue du Général Leclerc
city: Meaux
country: France
facility: Centre Hospitalier de Meaux
city: Nogent-sur-Marne
country: France
facility: Cabinet du Dr Deberdt
city: Nogent-sur-Marne
country: France
facility: Cabinet du Dr Wollner
city: Paris
country: France
facility: Cabinet du Dr Romain
city: Paris
country: France
facility: Cabinet du Dr Turberg-Romain
city: Paris
country: France
facility: Cabinet du Dr Michot
city: Paris
country: France
facility: Hospital Robert-Debré
city: Saint-Maur-des-Fossés
country: France
facility: Cabinet du Dr Cohen
city: Villeneuve-lès-Avignon
country: France
facility: Cabinet du Dr Werner
city: Villeneuve-Saint-Georges
country: France
facility: CHI Villeneuve-Saint-Georges
city: Vincennes
country: France
facility: 13 Villa Beauséjour
Study officials:
affiliation: CHI Créteil
name: Fouad MADHI, MD
role: PRINCIPAL_INVESTIGATOR
References: