Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections

NCT02897609 | Completed DMC

• 1 other identifier: BETA-LACTA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Infection

Keywords

Beta-lactamine; β-lactamine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

A simple questionary filled

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients may have a urinary infection ESBLE

You may qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

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

Location

Related Publications (1)

• 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.

  PMID: 32960659 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alban LE MONNIER, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 13, 2016
• Study Start: April 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 10, 2018

Record last verified: 2016-09

Locations

FR (1)