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

Study acronym: MIKA
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated August 27, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary and study completion dates: Jan 2025 to Jul 2026
    • Start date: Jan 18, 2019 to Jan 19, 2019
    v7
  2. Notable Primary and study completion dates: Jan 2023 to Jan 2025v6
  3. Minor 2 versions Re-verified since Nov 18, 2021, no change to tracked fieldsv4-v5
  4. Notable Primary and study completion dates: Jan 2021 to Jan 2023
    • Study sites: 43 to 20
    v3
  5. Minor Primary completion date: Sep 1, 2020 to Jan 2021
    • Study completion date: Dec 1, 2020 to Jan 2021
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03825874
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Conditions
(from sponsor)
Urinary Tract Infections, Urinary Tract Infections in Children
Related terms Urinary Tract Infections
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov