Nfections, EnterobacterialCARBANCT04995965
Infections With Enterobacteria Producing Carbapenemases at the University Hospitals of Strasbourg
An observational study of Nfections, Enterobacterial, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Infections with enterobacteria producing carbapenemases at the University Hospitals of Strasbourg - descriptive epidemiology and risk factors for infection in the event of colonization There is a worrying situation of an increase in the number of patients colonized with carbapenemase-producing Enterobacteriaceae (CPE)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nfections, Enterobacterial
- How many people
- 274 participants
- Where
- 1 siteFrance
- Study dates
- 6 Aug 2021to 6 Jan 2022
- 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
- Adult, Older adult
Study population: Major subject with clinical sample or rectal screening smear finding an enterobacterium producing a carbapenemase
Who may be able to join
- Major subject (≥18 years old)
- Subject hospitalized at HUS between 01/01/2011 and 07/31/2021
- Clinical sample or rectal screening smear finding an enterobacterium producing a carbapenemase (EPC)
- Subject not having expressed their opposition to participating in the study
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Yves HANSMANN, MD, PhD, 33 3 69 55 09 78, yves.hansmann@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Official title: Infections With Enterobacteria Producing Carbapenemases at the University Hospitals of Strasbourg - Descriptive Epidemiology and Risk Factors for Infection in the Event of Colonization
Infections with enterobacteria producing carbapenemases at the University Hospitals of Strasbourg - descriptive epidemiology and risk factors for infection in the event of colonization
There is a worrying situation of an increase in the number of patients colonized with carbapenemase-producing Enterobacteriaceae (CPE) at HUS.
7 to 15% of patients colonized with EPC would develop an infection with EPC. The cohorts published mainly concern patients hospitalized in intensive care. The associated mortality reported in the literature is high (> 25%) and greater than that associated with infection with the same bacterium sensitive to carbapenems.
- Conditions
- Nfections, Enterobacterial
- Keywords
- nfections, Enterobacterial, carbapenemases, producers of a carbapenemase
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of Enterobacteriaceae infections producing carbapenemases
Measured: Files analysed retrospectively from January 01, 2011 to July 31, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start6 Aug 2021
- Primary completion6 Jan 2022 (estimated)
- Study completion6 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nfections, EnterobacterialStudies 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
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves HANSMANN, MD, PhD, Principal investigator, Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995965
- Sponsor's protocol ID
- 8297
- Acronym
- CARBA
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 9 Aug 2021
- 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 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infections With Enterobacteria Producing Carbapenemases at the University Hospitals of Strasbourg - Descriptive Epidemiology and Risk Factors for Infection in the Event of Colonization
- ClinicalTrials.gov ID
- NCT04995965
- Acronym / sponsor ID
- CARBA / 8297
- Conditions
- Nfections, Enterobacterial
- Keywords
- nfections, Enterobacterial, carbapenemases, producers of a carbapenemase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 6 Jan 2022 (estimated)
- Study completion
- 6 Jan 2022 (estimated)
- First posted
- 9 Aug 2021 (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.
Infections with enterobacteria producing carbapenemases at the University Hospitals of Strasbourg - descriptive epidemiology and risk factors for infection in the event of colonization
There is a worrying situation of an increase in the number of patients colonized with carbapenemase-producing Enterobacteriaceae (CPE) at HUS.
7 to 15% of patients colonized with EPC would develop an infection with EPC. The cohorts published mainly concern patients hospitalized in intensive care. The associated mortality reported in the literature is high (> 25%) and greater than that associated with infection with the same bacterium sensitive to carbapenems.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject with clinical sample or rectal screening smear finding an enterobacterium producing a carbapenemase
Key inclusion criteria (4 listed)
- Major subject (≥18 years old)
- Subject hospitalized at HUS between 01/01/2011 and 07/31/2021
- Clinical sample or rectal screening smear finding an enterobacterium producing a carbapenemase (EPC)
- Subject not having expressed their opposition to participating in the study
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
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
Retrospective study of Enterobacteriaceae infections producing carbapenemases
Time frame: Files analysed retrospectively from January 01, 2011 to July 31, 2021 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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.
Yves HANSMANN, MD, PhD principal investigator
Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
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 Nfections, Enterobacterial, 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 4 inclusion and 3 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 9 Aug 2021. 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 Yves HANSMANN, MD, PhD (33 3 69 55 09 78, yves.hansmann@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of Enterobacteriaceae infections producing carbapenemases (time frame: Files analysed retrospectively from January 01, 2011 to July 31, 2021 will be examined]). 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 9 Aug 2021.