Infections, EnterobacteriaceaeSCREEN ICUNCT07345923
Predictive Value of a Rectal Swab With Detection of Enterobacteria (ESBL-E), Carbapenemases, and High-level Cephalosporinase (HLC) on the Risk of Infections With C3G-resistant Enterobacteria
An observational study of Infections, Enterobacteriaceae, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The objective of the research is to evaluate the value of testing for ESBL carriage by rectal swab to predict the risk of ESBL-producing Enterobacteriaceae infections in intensive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Enterobacteriaceae
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 patients who have undergone rectal screening for carriage of ESBL/HLC/carbapenemase-producing Enterobacteriaceae
Who may be able to join
- Adult patients (≥ 18 years old)
- Who have been in medical or surgical intensive care at Strasbourg University Hospitals (between January 1, 2024, and January 1, 2025)
- Who have undergone rectal screening for carriage of ESBL/HLC/carbapenemase-producing Enterobacteriaceae
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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: Predictive Value of a Rectal Swab With Detection of Enterobacteria (ESBL-E), Carbapenemases, and High-level Cephalosporinase (HLC) on the Risk of Infections With C3G-resistant Enterobacteria in Intensive Care
The objective of the research is to evaluate the value of testing for ESBL carriage by rectal swab to predict the risk of ESBL-producing Enterobacteriaceae infections in intensive care.
- Conditions
- Infections, Enterobacteriaceae
- Keywords
- Infections, Enterobacteriaceae, Enterobacterial Infections, High-level cephalosporinase, Carbapenemases, C3G-resistant enterobacteria
- Medical subject headings
- Enterobacteriaceae Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value of a negative rectal swab for the risk of infection with ESBL-producing Enterobacteriaceae
The negative predictive value (NPV) answers the following question:
When the test is negative, what is the probability that the person will not develop an infection with these resistant bacteria?
For example:
- Out of 100 people with a negative smear test,
- if 95 never develop an infection, then the negative predictive value is 95%.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start6 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, 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 only
- Time perspective
- Retrospective
- Enrolment
- 1,000 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
- NCT07345923
- Sponsor's protocol ID
- 9826
- Acronym
- SCREEN ICU
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of a Rectal Swab With Detection of Enterobacteria (ESBL-E), Carbapenemases, and High-level Cephalosporinase (HLC) on the Risk of Infections With C3G-resistant Enterobacteria in Intensive Care
- ClinicalTrials.gov ID
- NCT07345923
- Acronym / sponsor ID
- SCREEN ICU / 9826
- Conditions
- Infections, Enterobacteriaceae
- Keywords
- Infections, Enterobacteriaceae, Enterobacterial Infections, High-level cephalosporinase, Carbapenemases, C3G-resistant enterobacteria
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Jan 2026 (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.
The objective of the research is to evaluate the value of testing for ESBL carriage by rectal swab to predict the risk of ESBL-producing Enterobacteriaceae infections in intensive care.
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 patients who have undergone rectal screening for carriage of ESBL/HLC/carbapenemase-producing Enterobacteriaceae
Key inclusion criteria (3 listed)
- Adult patients (≥ 18 years old)
- Who have been in medical or surgical intensive care at Strasbourg University Hospitals (between January 1, 2024, and January 1, 2025)
- Who have undergone rectal screening for carriage of ESBL/HLC/carbapenemase-producing Enterobacteriaceae
Key exclusion criteria (1 listed)
- Refusal to participate in the study
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
Negative predictive value of a negative rectal swab for the risk of infection with ESBL-producing Enterobacteriaceae
Time frame: Up to 12 months
The negative predictive value (NPV) answers the following question: When the test is negative, what is the probability that the person will not develop an infection with these resistant bacteria? For example: * Out of 100 people with a negative smear test, * if 95 never develop an infection, then the negative predictive value is 95%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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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.
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 Infections, 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Negative predictive value of a negative rectal swab for the risk of infection with ESBL-producing Enterobacteriaceae (time frame: Up to 12 months). 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 16 Jan 2026.