Viewing Study NCT06652126



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Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06652126
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-23

Brief Title: Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
Sponsor: None
Organization: None

Study Overview

Official Title: Impact of Immunosuppression on Intensive Care Unit-acquired Multidrug-resistant Bacteria a Prospective Multicenter Study in Europe
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TANGERINE
Brief 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None