Critically-ill PatientsTANGERINENCT06652126
Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
An observational study of Critically-ill Patients, run by University Hospital, Lille at 1 site in France.
Trial summary
Antimicrobial resistance AMR is an emerging global threat to human health, and intensive care units (ICUs) are a 'hot spot' for the emergence and diffusion of multidrug-resistant (MDR) bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically-ill Patients
- What is being tested?
- Microbiological examinations.
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2025to 1 Dec 2029
- 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: Patients hospitalized in intensive care units (ICU).
Who may be able to join
- Patients aged 18 and over.
- Admitted to intensive care and whose length of stay is greater than 48 hours (inclusion is at the 48th hour after admission).
- Immunocompetent OR immunocompromised patients according to one of the following criteria:
- Solid cancer under treatment or in remission for less than 5 years (including cancers diagnosed during hospitalization in intensive care);
- Hematological malignancies under treatment or in remission for less than 5 years (including hematological malignancies diagnosed during hospitalization in intensive care);
- Neutropenia \< 0.7 G/L for ≥ 7 days;
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- Solid organ transplants;
- Patients with systemic or transplant pathologies requiring treatment with corticosteroids (prednisone equivalent \> 10 mg/day) or other high-dose immunosuppressants for \> 28 days;
- Human Immunodeficiency Virus (HIV) infection with CD4+ \<200 μL;
- Genetic immune deficiency.
- Patients undergoing invasive mechanical ventilation and/or vasopressive amines.
- Persons who have given their non-opposition. For patients unable to give their non-opposition, this will be obtained from the trusted support person. The patient will be informed as soon as possible and asked to agree to participate in any further research.
- Patients affiliated to a social security system.
Who cannot join
- Minor patients (\< 18 years),
- Length of stay in intensive care less than 48 hours,
- Moribund patients.
- Absence of BMR screening (rectal swab routinely, combined with nasal swab in some centers) within 48 hours of admission.
- Refusal to participate in the study.
- Vulnerable and/or susceptible patients according to one of the following criteria:
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- Patients under legal protection (guardianship, curatorship, etc.);
- Patients in prison;
- Pregnant or breast-feeding women.
- Patients without social security coverage.
- Simultaneous participation in another interventional study that could interfere with the evaluation of primary and secondary endpoints (particularly in the case of participation in an interventional study that could modulate the risk of CAR or BMR-ARI).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Louis Kreitmann contact
France1 site, 1 recruiting
- Recruiting
chu de Lille
Lille
Alexandre GAUDET, 03 20 44 59 62, alexandre.gaudet@chu-lille.fr
Louis Kreitmann, louis.kreitmann@gmail.com
About this study
Official title: Impact of Immunosuppression on Intensive Care Unit-acquired Multidrug-resistant Bacteria: a Prospective Multicenter Study in Europe
Antimicrobial resistance AMR is an emerging global threat to human health, and intensive care units (ICUs) are a 'hot spot' for the emergence and diffusion of multidrug-resistant (MDR) bacteria. ICU-acquired colonization and infection with MDR bacteria (ICU-MDR-col and ICU-MDR-inf, respectively) have been associated with higher ICU length-of-stay, duration of invasive mechanical ventilation and mortality. Immunocompromised patients account for an increasing proportion of ICU patients, and they are particularly prone to ICU-acquired infections, a significant proportion of which are caused by MDR pathogens. Recently, in a prospective multicenter study in France (CIMDREA, 8 ICUs, 750 patients), we found that immunocompromised patients had a lower cumulative incidence of ICU-MRD-col, but not ICU-MDR-inf (after adjustment for confounders). These results suggest that isolation measures and contact precautions could have a protective impact on cross-transmission of MDR bacteria in immunocompromised patients, even though our study fails to provide conclusive arguments for this. If confirmed, these findings could have an impact on antibiotic stewardship in immunocompromised critically-ill patients, a key element to control the spread of AMR in ICUs and beyond. Thus, we are planning to carry out the TANGERINE study, an observational prospective multicenter study in Europe, to confirm the findings of CIMDREA and provide a better understanding of the effect of isolation measures and contact precautions on the epidemiology of AMR in ICUs.
- Conditions
- Critically-ill Patients
- Being tested
- Microbiological examinations.
- Keywords
- Immunocompromised patients, antimicrobial resistance, intensive care unit, cross-infections
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological examinations.Other
- BMR testing by rectal swab (combined with nasal swab in some centers) on admission to the ICU and weekly as part of routine care.
- Microbiological samples (blood cultures, respiratory and urinary samples, etc.) as part of routine care at the request of the clinicians in charge of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Immunocompromised patients | * Age ≥ 18 ;
* Admitted to intensive care and whose length of stay exceeds 48 hours ;
* Immunocompromised according to one of the following criteria:
1. Solid cancer under treatment or in remission for less than 5 years (including cancers diagnosed during hospitalization in intensive care) ;
2. Hematologic malignancy under treatment or in remission for less than 5 years (including hematologic malignancies diagnosed during hospitalization in intensive care);
3. Neutropenia < 0.7 G/L for ≥ 7 days;
4. Solid organ transplants;
5. Patients with systemic or transplant pathologies requiring treatment with corticosteroids (prednisone equivalent > 10 mg/day) or other high-dose immunosuppressants for > 28 days;
6. Human Immunodeficiency Virus (HIV) infection with CD4+ <200 μL;
7. Genetic immune deficiency.
* Undergoing invasive mechanical ventilation and/or vasopressive amines. Receives: Other: Microbiological examinations. | |
| Immunocompetent patients | * Age ≥ 18 ;
* Admitted to intensive care and whose length of stay exceeds 48 hours ;
* Immunocompetent ;
* Undergoing invasive mechanical ventilation and/or vasopressive amines. Receives: Other: Microbiological examinations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the 28-day cumulative incidence of a composite outcome including ICU-MDR-col and/or ICU-MDR-inf between immunocompromised and non-immunocompromised patients.
Measured: End of ICU-stay or day 28 after ICU admission (whichever comes first)
Secondary outcomes (9)
To compare the 28-day cumulative incidence of ICU-MDR-col between immunocompromised and non-immunocompromised patients.
Measured: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To compare the 28-day cumulative incidence of ICU-MDR-inf between immunocompromised and non-immunocompromised patients.
Measured: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To compare the incidence rate of a composite outcome including ICU-MDR-col and/or ICU-MDR-inf between immunocompromised and non-immunocompromised patients.
Measured: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To compare the incidence rate of ICU-MDR-col between immunocompromised and non-immunocompromised patients.
Measured: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To compare the incidence rate of ICU-MDR-inf between immunocompromised and non-immunocompromised patients.
Measured: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To evaluate the effect of contact precautions and isolation measures on the 28-day cumulative incidence of ICU-MDR-col and ICU-MDR-inf in immunocompromised patients.
Measured: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To describe the microbiology of ICU-MDR-col and ICU-MDR-inf in immunocompromised and non-immunocompromised patients
Measured: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To assess the effect of the type of immunosuppression on the 28-day cumulative incidence of ICU-MDR-col and ICU-MDR-inf among immunocompromised patients.
Measured: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To evaluate the association of occurrence of ICU-MDR-col and ICU-MDR-inf and prognostic outcomes (ICU length-of-stay, duration of IMV and 28-day mortality) in the overall cohort and according to immune status (i.e., in immunocompromised and non-immunocom
Measured: End of ICU-stay or day 28 after ICU admission (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start19 Mar 2025
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically-ill PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652126
- Sponsor's protocol ID
- 2023_0226
- Other IDs
- 2023-A02489-36
- Acronym
- TANGERINE
- Status last verified
- May 2026
- First submitted
- 23 Sep 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immunosuppression on Intensive Care Unit-acquired Multidrug-resistant Bacteria: a Prospective Multicenter Study in Europe
- ClinicalTrials.gov ID
- NCT06652126
- Acronym / sponsor ID
- TANGERINE / 2023_0226
- Conditions
- Critically-ill Patients
- Keywords
- Immunocompromised patients, antimicrobial resistance, intensive care unit, cross-infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 22 Oct 2024 (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.
Antimicrobial resistance AMR is an emerging global threat to human health, and intensive care units (ICUs) are a 'hot spot' for the emergence and diffusion of multidrug-resistant (MDR) bacteria. ICU-acquired colonization and infection with MDR bacteria (ICU-MDR-col and ICU-MDR-inf, respectively) have been associated with higher ICU length-of-stay, duration of invasive mechanical ventilation and mortality. Immunocompromised patients account for an increasing proportion of ICU patients, and they are particularly prone to ICU-acquired infections, a significant proportion of which are caused by MDR pathogens. Recently, in a prospective multicenter study in France (CIMDREA, 8 ICUs, 750 patients), we found that immunocompromised patients had a lower cumulative incidence of ICU-MRD-col, but not ICU-MDR-inf (after adjustment for confounders). These results suggest that isolation measures and contact precautions could have a protective impact on cross-transmission of MDR bacteria in immunocompromised patients, even though our study fails to provide conclusive arguments for this. If confirmed, these findings could have an impact on antibiotic stewardship in immunocompromised critically-ill patients, a key element to control the spread of AMR in ICUs and beyond. Thus, we are planning to carry out the TANGERINE study, an observational prospective multicenter study in Europe, to confirm the findings of CIMDREA and provide a better understanding of the effect of isolation measures and contact precautions on the epidemiology of AMR in ICUs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunocompromised patients | – | Other: Microbiological examinations.* Age ≥ 18 ; * Admitted to intensive care and whose length of stay exceeds 48 hours ; * Immunocompromised according to one of the following criteria: 1. Solid cancer under treatment or in remission for less than 5 years (including cancers diagnosed during hospitalization in intensive care) ; 2. Hematologic malignancy under treatment or in remission for less than 5 years (including hematologic malignancies diagnosed during hospitalization in intensive care); 3. Neutropenia < 0.7 G/L for ≥ 7 days; 4. Solid organ transplants; 5. Patients with systemic or transplant pathologies requiring treatment with corticosteroids (prednisone equivalent > 10 mg/day) or other high-dose immunosuppressants for > 28 days; 6. Human Immunodeficiency Virus (HIV) infection with CD4+ <200 μL; 7. Genetic immune deficiency. * Undergoing invasive mechanical ventilation and/or vasopressive amines. |
| Immunocompetent patients | – | Other: Microbiological examinations.* Age ≥ 18 ; * Admitted to intensive care and whose length of stay exceeds 48 hours ; * Immunocompetent ; * Undergoing invasive mechanical ventilation and/or vasopressive amines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in intensive care units (ICU).
Key inclusion criteria (13 listed)
- Patients aged 18 and over.
- Admitted to intensive care and whose length of stay is greater than 48 hours (inclusion is at the 48th hour after admission).
- Immunocompetent OR immunocompromised patients according to one of the following criteria:
- Patients undergoing invasive mechanical ventilation and/or vasopressive amines.
- Persons who have given their non-opposition. For patients unable to give their non-opposition, this will be obtained from the trusted support person. The patient will be informed as soon as possible and asked to agree to participate in any further research.
Key exclusion criteria (11 listed)
- Minor patients (\&lt; 18 years),
- Length of stay in intensive care less than 48 hours,
- Moribund patients.
- Absence of BMR screening (rectal swab routinely, combined with nasal swab in some centers) within 48 hours of admission.
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiological examinations.* BMR testing by rectal swab (combined with nasal swab in some centers) on admission to the ICU and weekly as part of routine care. * Microbiological samples (blood cultures, respiratory and urinary samples, etc.) as part of routine care at the request of the clinicians in charge of the patient. | Other | Immunocompetent patients, Immunocompromised patients |
Primary outcome
To compare the 28-day cumulative incidence of a composite outcome including ICU-MDR-col and/or ICU-MDR-inf between immunocompromised and non-immunocompromised patients.
Time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)
9 secondary outcomes
To compare the 28-day cumulative incidence of ICU-MDR-col between immunocompromised and non-immunocompromised patients.
Time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To compare the 28-day cumulative incidence of ICU-MDR-inf between immunocompromised and non-immunocompromised patients.
Time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To compare the incidence rate of a composite outcome including ICU-MDR-col and/or ICU-MDR-inf between immunocompromised and non-immunocompromised patients.
Time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To compare the incidence rate of ICU-MDR-col between immunocompromised and non-immunocompromised patients.
Time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To compare the incidence rate of ICU-MDR-inf between immunocompromised and non-immunocompromised patients.
Time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To evaluate the effect of contact precautions and isolation measures on the 28-day cumulative incidence of ICU-MDR-col and ICU-MDR-inf in immunocompromised patients.
Time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To describe the microbiology of ICU-MDR-col and ICU-MDR-inf in immunocompromised and non-immunocompromised patients
Time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To assess the effect of the type of immunosuppression on the 28-day cumulative incidence of ICU-MDR-col and ICU-MDR-inf among immunocompromised patients.
Time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)
To evaluate the association of occurrence of ICU-MDR-col and ICU-MDR-inf and prognostic outcomes (ICU length-of-stay, duration of IMV and 28-day mortality) in the overall cohort and according to immune status (i.e., in immunocompromised and non-immunocom
Time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)
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 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Louis Kreitmann contact
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 Critically-ill Patients, run by University Hospital, Lille 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 13 inclusion and 11 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 21 Oct 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 Saad NSEIR, Professor (33 (0)3 20 44 44 95, saadalla.nseir@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the 28-day cumulative incidence of a composite outcome including ICU-MDR-col and/or ICU-MDR-inf between immunocompromised and non-immunocompromised patients. (time frame: End of ICU-stay or day 28 after ICU admission (whichever comes first)). 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 21 Oct 2026.