Clinical trial NCT02897609: Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections
Official title: Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Infection
Keywords: Beta-lactamine
β-lactamine
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients may have a urinary infection ESBLE

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. 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Assessment of the relevance between antibiotic susceptibility and the antibiotic chosen,with phone questionary
timeFrame: Hour 48
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Alban LE MONNIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.