Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amikacin, usual antibiotic treatment.
- Who it may be relevant to
- Registry conditions: Urinary Tract Infections, Urinary Tract Infections in Children. Basic parameters: 3 months — 3 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Amikacin
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. - Other usual antibiotic treatment
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.
Primary outcome measures
- Presence of E-BLSE in stools [Time frame: day 4]
Secondary outcome measures (5)
- Type of E-BLSE strain in stools [Time frame: day 4]
- Rate of enzymatic resistance of E-BLSE strain in stools [Time frame: 4 days]
- Fever [Time frame: 4 days]
- side effects due to antibiotic therapy [Time frame: at 1.5 months]
- rate of relapse of urinary tract infection [Time frame: 1.5 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
France · 20 centers
- Cabinet du Dr Benali — Charenton-le-Pont
- Cabinet du Dr Coicadan — Chennevières-sur-Marne
- Cabinet du Dr Corrard — Combs-la-Ville
- Cabinet du Dr Thollot — Essey-lès-Nancy
- CHU Le Kremlin-Bicêtre — Le Kremlin-Bicêtre
- 157 Avenue du Général Leclerc — Maisons-Alfort
- Centre Hospitalier de Meaux — Meaux
- Cabinet du Dr Deberdt — Nogent-sur-Marne
- … and 12 more centers
Identifiers
NCT: NCT03825874 · MIKA · 2017-A02372-51