Clinical Trial

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

Study acronym: MIKA
Recruiting
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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.
Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2019-01-30; most recent amendment 2025-08-26.
Trial Details
NCT Number NCT03825874
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Conditions Urinary Tract Infections, Urinary Tract Infections in Children
Enrollment 200 participants
Start Date 2019-01-19
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-08-27