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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Presence of E-BLSE in stools [Срок оценки: day 4]

Вторичные конечные точки (5)

• Type of E-BLSE strain in stools [Срок оценки: day 4]
• Rate of enzymatic resistance of E-BLSE strain in stools [Срок оценки: 4 days]
• Fever [Срок оценки: 4 days]
• side effects due to antibiotic therapy [Срок оценки: at 1.5 months]
• rate of relapse of urinary tract infection [Срок оценки: 1.5 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 20 центров

• 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
• … и ещё 12 центров

Идентификаторы

NCT: NCT03825874 · MIKA · 2017-A02372-51

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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