Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections

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. 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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Key information

Conditions

Urinary Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

About this study

Main objective / secondary:

The investigators propose to conduct a study with a double objective:

To assess the analytical performance and its positioning relative to all the tests available to us in urine samples,
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients may have a urinary infection ESBLE
Patients accepting the use of their result for analysis.

Exclusion criteria

No exclusion criteria

Treatment and study plan

Primary outcomes

Assessment of the relevance between antibiotic susceptibility and the antibiotic chosen,with phone questionary

Time frame: Hour 48

The biologist advise, as usual, the physician about the antibiotic to choose at H0 according to the result of Beta Lacta™Test. After the first result given, the biologist ask, at hour 48,the physician about the antibiotic chosen and determine the relevance according to the antibiotic susceptibility.

The answer can be yes or no.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Sep 13, 2016
Registry last updated: Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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