Drug Resistance, Multiple, BacterialBLSE-REANCT05833282
Prognostic Factors and Therapeutic Management of ESBL Enterobacteriaceae in the ICU
An observational study of Drug Resistance, Multiple, Bacterial, run by Tourcoing Hospital at 1 site in France.
Trial summary
Multicenter retrospective study conducted in the intensive care units of Tourcoing, Roubaix, and Lille hospitals. Patients hospitalized in the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU will be selected from microbiology laboratory data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Resistance, Multiple, Bacterial
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 30 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU with EBLSE bacteremia
Who may be able to join
- Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.
Who cannot join
- Patient who is a minor, protected adult, or who refuses to participate.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier DRON
Tourcoing, 59208
MEYBECK Agnès, MD, 0320694949, recherche@ch-touroing.fr
About this study
Multicenter retrospective study conducted in the intensive care units of Tourcoing, Roubaix, and Lille hospitals. Patients hospitalized in the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU will be selected from microbiology laboratory data. Patient demographics and clinical data will be collected from the medical record. Microbiological results will be collected from the laboratory data.
Read the detailed description
INCLUSION CRITERIA - Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.
PRIMARY ENDPOINT
- The primary endpoint is 30-day mortality.
- Conditions
- Drug Resistance, Multiple, Bacterial
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is all-cause 30-day mortality.
all-cause mortality.
Measured: 30-day mortality
Secondary outcomes (1)
Adequacy of initial antibiotic therapy to french recommendations
Antibiotic prescriptions will be considered adequate if all of the following criteria meet the recommendations: molecule, dose, according to the recommendations provided by the French Society of Infectious Diseases. The recommendations for prescribing antibiotics are similar to those proposed by international guidelines.
Measured: adequate within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistance, Multiple, BacterialStudies 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833282
- Sponsor's protocol ID
- NRIPH_2023_01
- Acronym
- BLSE-REA
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors and Therapeutic Management of ESBL Enterobacteriaceae in the ICU
- ClinicalTrials.gov ID
- NCT05833282
- Acronym / sponsor ID
- BLSE-REA / NRIPH_2023_01
- Conditions
- Drug Resistance, Multiple, Bacterial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Apr 2023 (actual)
- 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.
Multicenter retrospective study conducted in the intensive care units of Tourcoing, Roubaix, and Lille hospitals. Patients hospitalized in the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU will be selected from microbiology laboratory data. Patient demographics and clinical data will be collected from the medical record. Microbiological results will be collected from the laboratory data.
Detailed description
INCLUSION CRITERIA - Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.
PRIMARY ENDPOINT
- The primary endpoint is 30-day mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU with EBLSE bacteremia
Key inclusion criteria (1 listed)
- Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.
Key exclusion criteria (1 listed)
- Patient who is a minor, protected adult, or who refuses to participate.
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
The primary endpoint is all-cause 30-day mortality.
Time frame: 30-day mortality
all-cause mortality.
1 secondary outcome
Adequacy of initial antibiotic therapy to french recommendations
Time frame: adequate within 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- 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.
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 Drug Resistance, Multiple, Bacterial, run by Tourcoing Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MEYBECK Angès, MD (0320694238, recherche@ch-tourcoing.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is all-cause 30-day mortality. (time frame: 30-day mortality). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2023.