Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria

ConditionCritically-ill Patients

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

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);

Disqualifiers

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.

Trial population

Patients hospitalized in intensive care units (ICU).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Microbiological examinations.
Other intervention
* 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.

Treatment groups

1,000 Participants

are divided into 2 treatment groups

Group A: Immunocompromised patients1 intervention

Group B: Immunocompetent patients1 intervention

Trial outcomes

Primary outcomes

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