NCT03825874 Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
| NCT ID | NCT03825874 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Intercommunal Creteil |
| Condition | Urinary Tract Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-01-19 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2019-01-19 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Fouad MADHI, MD
PRINCIPAL INVESTIGATOR
CHI Créteil
Frequently Asked Questions
Who can join the NCT03825874 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 3 Years, studying Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03825874 currently recruiting?
Yes, NCT03825874 is actively recruiting participants. Contact the research team at fouad.madhi@chicreteil.fr for enrollment information.
Where is the NCT03825874 trial being conducted?
This trial is being conducted at Charenton-le-Pont, France, Chennevières-sur-Marne, France, Combs-la-Ville, France, Essey-lès-Nancy, France and 11 additional locations.
Who is sponsoring the NCT03825874 clinical trial?
NCT03825874 is sponsored by Centre Hospitalier Intercommunal Creteil. The principal investigator is Fouad MADHI, MD at CHI Créteil. The trial plans to enroll 200 participants.