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
This trial does not accept healthy volunteersQualifiers
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 population
Child from 3 months to 3 years treated for febrile urinary tract infection
Trial design
Other
Prospective
Treatments tested in this trial
Amikacin
Other interventionA 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.
usual antibiotic treatment
Other interventionA 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.
Treatment groups
Trial outcomes
Primary outcomes
Presence of E-BLSE in stools
ano-rectal swab
Secondary outcomes
Type of E-BLSE strain in stools
Rate of enzymatic resistance of E-BLSE strain in stools
Fever
Time of apyrexia
side effects due to antibiotic therapy
Sponsors and contacts
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