Viewing Study NCT03825874



Ignite Creation Date: 2024-05-06 @ 12:42 PM
Last Modification Date: 2024-10-26 @ 1:02 PM
Study NCT ID: NCT03825874
Status: RECRUITING
Last Update Posted: 2023-01-26
First Post: 2018-08-08

Brief Title: Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
Sponsor: Centre Hospitalier Intercommunal Creteil
Organization: Centre Hospitalier Intercommunal Creteil

Study Overview

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
Status: RECRUITING
Status Verified Date: 2023-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MIKA
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2017-A02372-51 OTHER ID-RCB None