Trials / Not Yet Recruiting
Not Yet RecruitingNCT06652126
Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
Impact of Immunosuppression on Intensive Care Unit-acquired Multidrug-resistant Bacteria: a Prospective Multicenter Study in Europe
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
Timeline
- Start date
- 2024-11-01
- Primary completion
- 2029-12-01
- Completion
- 2029-12-01
- First posted
- 2024-10-22
- Last updated
- 2024-10-22
Source: ClinicalTrials.gov record NCT06652126. Inclusion in this directory is not an endorsement.