Clinical Trial

Impact of a Risk Stratification Tool on the Outcome of Liver Transplant Recipients Colonized With Carbapenem Resistant Enterobacteriaceae: an Observational Study

Active, Not Recruiting
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Summary
Although CRE infection after OLT have a dramatic impact on patient survival and several implementations have been proposed (i.e. preventive strategies or targeted surgical prophylaxis), a standardized approach in colonized patients is still missing. The investigators recently developed and internally validated a bed-side score to stratify the risk of CRE infection in OLT recipients colonized by CRE. The goal of this pre/post observational study is to investigate the impact on all-cause 90-day mortality in OLT recipients colonized with CRE using such score (CRECOOLT score) for the systematic evaluation of CRE infection risk. The secondary objectives are: * To analyse days of therapy with anti-CRE antibiotic regimens in patients with and without systematic evaluation of CRE infection risk, according to clinical practices. * To evaluate rates of documented CRE infections and their relapses with selection of further resistance in patients with and without systematic evaluation of CRE infection risk. * To evaluate the length of hospital, ICU stay and rates of hospital readmission in patients with and without systematic evaluation of CRE infection risk.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-10-21; most recent amendment 2025-03-24.
Status change: Recruiting → Active, Not Recruiting 2025-03-24
Status change: Not Yet Recruiting → Recruiting 2024-07-19
Trial Details
NCT Number NCT05594901
Lead Sponsor University of Bologna
Collaborators: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Università degli Studi dell'Insubria, Università degli Studi di Padova Unit Multivisceral Transplant Unit Padova, Università degli Studi di Verona - Gastroenterologia Verona, Hospital General Universitario Gregorio Marañon, University of Sao Paulo
Conditions Liver Transplantation, Carbapenem-Resistant Enterobacteriaceae Colonization
Enrollment 240 participants
Start Date 2022-11-01
Primary Completion 2024-10-31 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-25