Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02897609
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2016-09-01
Brief Title:
Clinical Evaluation of Beta-Lacta Test in Urinary Infections
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Clinical Evaluation of Beta-Lacta Test in Urinary Infections
Status:
COMPLETED
Status Verified Date:
2016-09
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:
None
Brief Summary:
3rd generation cephalosporins C3G are the antibiotics recommended in probabilistic in most enteric infections in France including pyelonephritis and bacteraemia
However the prevalence of resistance of Enterobacteriaceae including E coli to C3G is continuously increasing for several years In 2012 in France the proportion of E resistant or intermediate coli categorized to C3G is 10 to 25 EARSS data
Antibiotics not adapted early in severe sepsis is responsible for worse prognosis for patients in terms of morbidity and mortality and unnecessary prolongation of the DMS
At St Josephs Hospital on enterobacteria levels of resistance to C3G is 154
To avoid overuse of carbapenems for probabilistic antibiotic and to quickly prescribe antibiotics adapted to the resistance of the bacteria it is interesting to use a rapid test for detection of resistance to C3G
The Lacta test could be used in this indication This is a rapid test diagnostic orientation detecting hydrolysis of a substrate chromogenic cephalosporin by the enzymatic action of ESBL cAMP-type cephalosporinases and carbapenemases This test was initially marketed for rapid detection of resistance to C3G enterobacteria from isolated bacterial colonies in culture
However the prevalence of resistance of Enterobacteriaceae including E coli to C3G is continuously increasing for several years In 2012 in France the proportion of E resistant or intermediate coli categorized to C3G is 10 to 25 EARSS data
Antibiotics not adapted early in severe sepsis is responsible for worse prognosis for patients in terms of morbidity and mortality and unnecessary prolongation of the DMS
At St Josephs Hospital on enterobacteria levels of resistance to C3G is 154
To avoid overuse of carbapenems for probabilistic antibiotic and to quickly prescribe antibiotics adapted to the resistance of the bacteria it is interesting to use a rapid test for detection of resistance to C3G
The Lacta test could be used in this indication This is a rapid test diagnostic orientation detecting hydrolysis of a substrate chromogenic cephalosporin by the enzymatic action of ESBL cAMP-type cephalosporinases and carbapenemases This test was initially marketed for rapid detection of resistance to C3G enterobacteria from isolated bacterial colonies in culture
Detailed Description:
Main objective secondary
The investigators propose to conduct a study with a double objective
1 To assess the analytical performance and its positioning relative to all the tests available to us in urine samples
2 To evaluate prospectively the clinical impact test in urinary infections
Expected results and prospects
This study will define the performance and limitations of this test in the most difficult situations low number of bacteria ml haematic urine and will specify its indications and its place among all other tests before implanting it in our routine as appropriate
The clinical impact study will provide medical and economic analysis data including shortening time to adapt antibiotic therapies and put in septic isolation to argue the implementation of this test routinely
The investigators propose to conduct a study with a double objective
1 To assess the analytical performance and its positioning relative to all the tests available to us in urine samples
2 To evaluate prospectively the clinical impact test in urinary infections
Expected results and prospects
This study will define the performance and limitations of this test in the most difficult situations low number of bacteria ml haematic urine and will specify its indications and its place among all other tests before implanting it in our routine as appropriate
The clinical impact study will provide medical and economic analysis data including shortening time to adapt antibiotic therapies and put in septic isolation to argue the implementation of this test routinely
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