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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-3
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Amikacin
  • usual antibiotic treatment

Treatment groups

200 Participants
are divided into 2 treatment groups