Viewing Study NCT02681263



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Last Modification Date: 2024-10-26 @ 11:57 AM
Study NCT ID: NCT02681263
Status: UNKNOWN
Last Update Posted: 2018-06-06
First Post: 2015-11-27

Brief Title: Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae
Sponsor: University Hospital Grenoble
Organization: University Hospital Grenoble

Study Overview

Official Title: Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae
Status: UNKNOWN
Status Verified Date: 2018-06
Last Known Status: ACTIVE_NOT_RECRUITING
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: TEMO-ESBL
Brief Summary: The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae resistant to quinolones and Bactrim in France In addition this study will describe and support the use of high dose 6gday of temocillin which could be of interest for the treatment urinary tract infection due to multi-resistant bacteria having high MIC up to 32 mgL The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
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
2015-004178-14 EUDRACT_NUMBER None None