Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections

Urinary Infection Clinical Trial

Official title:

Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897609
• Other study ID #: BETA-LACTA
• Status: Completed
• Start date: April 2014
• Est. completion date: January 2015

Study information

• Verified date: September 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients may have a urinary infection ESBLE

• Patients accepting the use of their result for analysis.

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the relevance between antibiotic susceptibility and the antibiotic chosen,with phone questionary	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.	Hour 48