Urinary InfectionNCT02897609
Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections
An observational study of Urinary Infection, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Infection
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients may have a urinary infection ESBLE
Who may be able to join
- Patients may have a urinary infection ESBLE
- Patients accepting the use of their result for analysis.
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Urinary Infection
- Keywords
- Beta-lactamine, β-lactamine
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A simple questionary filled | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hour 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startApr 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alban LE MONNIER, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897609
- Sponsor's protocol ID
- BETA-LACTA
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 32960659
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections
- ClinicalTrials.gov ID
- NCT02897609
- Acronym / sponsor ID
- BETA-LACTA
- Conditions
- Urinary Infection
- Keywords
- Beta-lactamine, β-lactamine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A simple questionary filled | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients may have a urinary infection ESBLE
Key inclusion criteria (2 listed)
- Patients may have a urinary infection ESBLE
- Patients accepting the use of their result for analysis.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Derived from this study: PubMed 32960659Mizrahi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alban LE MONNIER, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Infection, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the relevance between antibiotic susceptibility and the antibiotic chosen,with phone questionary (time frame: Hour 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02897609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.