Immunosuppression and ICU-acquired MDROs in critically ill adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, multicenter study in ICUs focusing on ICU-acquired multidrug-resistant bacteria in adults, including both immunocompetent and immunocompromised patients. The project collects microbiological data to track colonization and infections by resistant pathogens after at least 48 hours in the ICU. It builds on prior findings that isolation measures may influence cross-transmission in immunocompromised patients. The aim is to characterize the frequency and patterns of ICU-MDR colonization and infection and explore factors associated with transmission. No interventional therapies are tested; the study analyzes real-world data to inform infection control priorities in ICUs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged 18 and over.
2. Admitted to intensive care and whose length of stay is greater than 48 hours (inclusion is at the 48th hour after admission).
3. Immunocompetent OR immunocompromised patients 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. Hematological malignancies under treatment or in remission for less than 5 years (including hematological 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.
4. Patients undergoing invasive mechanical ventilation and/or vasopressive amines.
5. 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.
6. Patients affiliated to a social security system.

Exclusion Criteria:

1. Minor patients (\< 18 years),
2. Length of stay in intensive care less than 48 hours,
3. Moribund patients.
4. Absence of BMR screening (rectal swab routinely, combined with nasal swab in some centers) within 48 hours of admission.
5. Refusal to participate in the study.
6. Vulnerable and/or susceptible patients according to one of the following criteria:

   1. Patients under legal protection (guardianship, curatorship, etc.);
   2. Patients in prison;
   3. Pregnant or breast-feeding women.
7. Patients without social security coverage.
8. 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).

Where it's running

• chu de Lille
  Lille, France Recruiting

Study contacts

• Study coordinator: Saad NSEIR, Professor
• Email: saadalla.nseir@chu-lille.fr
• Phone: 33 (0)3 20 44 44 95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.