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

C

Centre Hospitalier Intercommunal Creteil

Status

Enrolling

Conditions

Urinary Tract Infections in Children
Urinary Tract Infections

Treatments

Other: usual antibiotic treatment
Other: Amikacin

Study type

Observational

Funder types

Other

Identifiers

NCT03825874
MIKA
2017-A02372-51 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

3 months to 3 years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

amikacin IV
Description:
Febrile urinary tract infection treated with amikacin IV
Treatment:
Other: Amikacin
Other antibiotics
Description:
Febrile urinary tract infection treated with other antibiotic, according to the recommendations: ceftriaxone or cefixime
Treatment:
Other: usual antibiotic treatment

Trial contacts and locations

20

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Central trial contact

Fouad Madhi, MD

Data sourced from clinicaltrials.gov

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