BacteremiaCARBAPENEMNCT05535751
Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections
An observational study of Bacteremia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2022to 20 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: Adult patient (≥18 years of age) managed within a study center for high-grade cephalosporinase-producing bacteremia
Who may be able to join
- Adult patient (≥18 years of age)
- managed within a study center for high-grade cephalosporinase-producing bacteremia
- Not objecting to the reuse of their health data for scientific research purposes.
Who cannot join
- Patient who has expressed opposition to the reuse of their data for scientific research purposes.
- Resistance to Cefepime or carbapenems
- Multiple bacteremia
- Treatment with a molecule other than Cefepime or carbapenem.
Trial locations and contacts
1 site in 1 country.
France1 site
Service des maladies infectieuses et tropicales - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.
- Conditions
- Bacteremia
- Keywords
- Bacteremia, Cefepime, carbapenems, AmpC β-lactamase, enterobacteriaceae bloodstream infections
- Medical subject headings
- Bacteremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Measured: 30 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 posted10 Sep 2022
- Study start20 Jul 2022
- Primary completion20 May 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
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
- NCT05535751
- Sponsor's protocol ID
- 8660
- Acronym
- CARBAPENEM
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2022
- Last updated
- 13 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections
- ClinicalTrials.gov ID
- NCT05535751
- Acronym / sponsor ID
- CARBAPENEM / 8660
- Conditions
- Bacteremia
- Keywords
- Bacteremia, Cefepime, carbapenems, AmpC β-lactamase, enterobacteriaceae bloodstream infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 10 Sep 2022 (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.
Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.
Study design
- Observational model
- Case only
- 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 years of age) managed within a study center for high-grade cephalosporinase-producing bacteremia
Key inclusion criteria (3 listed)
- Adult patient (≥18 years of age)
- managed within a study center for high-grade cephalosporinase-producing bacteremia
- Not objecting to the reuse of their health data for scientific research purposes.
Key exclusion criteria (4 listed)
- Patient who has expressed opposition to the reuse of their data for scientific research purposes.
- Resistance to Cefepime or carbapenems
- Multiple bacteremia
- Treatment with a molecule other than Cefepime or carbapenem.
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
Hospital mortality
Time frame: 30 days after infection
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 13 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bacteremia, 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 4 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 13 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?
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?
Hospital mortality (time frame: 30 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 13 Dec 2023.