Carbapenemase-Producing EnterobacteriaceaeCarbaVimNCT06185153
Carbapenem Antibiotic Therapy for VIM Carbapenemase-Producing Enterobacteriaceae Infections
An observational study of Carbapenemase-Producing Enterobacteriaceae, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Carbapenemase-producing Enterobacteriaceae (CPE) infections are emerging infections that pose a therapeutic challenge. These infections mainly occur in patients with prolonged hospitalization and repeated exposure to antibiotics. Certain strains, notably VIM-producing strains, may remain sensitive to carbapenems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbapenemase-Producing Enterobacteriaceae
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2022to Dec 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: - Adult patient (≥18) treated at the HUS for a VIM-producing enterobacteria infection between 01/01/2011 and 11/30/2022
Who may be able to join
- Adult patient (≥18)
- Treated at the HUS for a VIM-producing enterobacteria infection between 01/01/2011 and 11/30/2022
- Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.
Who cannot join
- Patient having expressed his opposition to the retrospective reuse of his data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Strasbourg, 67091
Baptiste HOELLINGER, MD, 33 3 69 55 05 45, baptiste.hoellinger@chru-strasbourg.fr
Baptiste HOELLINGER, MD
About this study
Official title: Carbapenem Antibiotic Therapy for VIM Carbapenemase-Producing Enterobacteriaceae Infections - A Retrospective Cohort Study
Carbapenemase-producing Enterobacteriaceae (CPE) infections are emerging infections that pose a therapeutic challenge. These infections mainly occur in patients with prolonged hospitalization and repeated exposure to antibiotics. Certain strains, notably VIM-producing strains, may remain sensitive to carbapenems. CPE VIM strains are rare in France, but represent the main CPE strains in many countries. They are historically the main type of carbapenemases isolated at the Strasbourg University Hospital.
Read the detailed description
The circulation of multi-antibiotic-resistant bacterial strains is significant at the Strasbourg University Hospital and the investigators wish to report their local experience in the use of carbapenems in infections with enterobacteria producing carbapenemase type VIM.
- Keywords
- Carbapenemase, Enterobacteriaceae, VIM-producing strains
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 28 days
Measured: Mortality at 28 days after infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start21 Nov 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenemase-Producing EnterobacteriaceaeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185153
- Sponsor's protocol ID
- 8779
- Acronym
- CarbaVim
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbapenem Antibiotic Therapy for VIM Carbapenemase-Producing Enterobacteriaceae Infections - A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06185153
- Acronym / sponsor ID
- CarbaVim / 8779
- Keywords
- Carbapenemase, Enterobacteriaceae, VIM-producing strains
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 29 Dec 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.
Carbapenemase-producing Enterobacteriaceae (CPE) infections are emerging infections that pose a therapeutic challenge. These infections mainly occur in patients with prolonged hospitalization and repeated exposure to antibiotics. Certain strains, notably VIM-producing strains, may remain sensitive to carbapenems. CPE VIM strains are rare in France, but represent the main CPE strains in many countries. They are historically the main type of carbapenemases isolated at the Strasbourg University Hospital.
Detailed description
The circulation of multi-antibiotic-resistant bacterial strains is significant at the Strasbourg University Hospital and the investigators wish to report their local experience in the use of carbapenems in infections with enterobacteria producing carbapenemase type VIM.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adult patient (≥18) treated at the HUS for a VIM-producing enterobacteria infection between 01/01/2011 and 11/30/2022
Key inclusion criteria (3 listed)
- Adult patient (≥18)
- Treated at the HUS for a VIM-producing enterobacteria infection between 01/01/2011 and 11/30/2022
- Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.
Key exclusion criteria (1 listed)
- Patient having expressed his opposition to the retrospective reuse of his data for scientific research purposes.
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
Mortality at 28 days
Time frame: Mortality at 28 days after infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
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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 Carbapenemase-Producing Enterobacteriaceae, run by University Hospital, Strasbourg, France 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 3 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 29 Dec 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 Baptiste HOELLINGER, MD (33 3 69 55 05 45, baptiste.hoellinger@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 28 days (time frame: Mortality at 28 days after infection). 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 29 Dec 2023.