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

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2024 to Jun 30, 2025
    • Site details revised at 6 of 6 sites
    v4
  2. Collaborators revised (6)v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 6 of 6 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Liver Transplantation, Carbapenem-Resistant Enterobacteriaceae Colonization
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov