Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections
NCT ID: NCT02897609
Last Updated: 2018-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2014-04-30
2015-01-31
Brief Summary
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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. Joseph's Hospital on enterobacteria levels of resistance to C3G is 15.4%.
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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A simple questionary filled
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients accepting the use of their result for analysis.
ALL
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Principal Investigators
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Alban LE MONNIER, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Hôpital Saint-Joseph
Locations
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Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, France
Countries
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References
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Mizrahi A, Naouri D, Hobson C, Amzalag J, Pilmis B, Couzigou C, Ganansia O, Le Monnier A. Impact of the beta-lacta test on the management of urinary tract infections at the emergency department. Infect Dis (Lond). 2021 Jan;53(1):52-60. doi: 10.1080/23744235.2020.1822543. Epub 2020 Sep 22.
Other Identifiers
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BETA-LACTA
Identifier Type: -
Identifier Source: org_study_id
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