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

This trial does not accept healthy volunteers

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 population

Child from 3 months to 3 years treated for febrile urinary tract infection

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Amikacin

    Other intervention

    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.

  • usual antibiotic treatment

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: amikacin IV1 intervention
Group B: Other antibiotics1 intervention

Trial outcomes

Primary outcomes

1

Presence of E-BLSE in stools

ano-rectal swab

Time frame
day 4

Secondary outcomes

1

Type of E-BLSE strain in stools

Time frame
day 4
2

Rate of enzymatic resistance of E-BLSE strain in stools

Time frame
4 days
3

Fever

Time of apyrexia

Time frame
4 days
4

side effects due to antibiotic therapy

Time frame
at 1.5 months

Other outcomes

Sponsors and contacts

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