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ACTIVE NOT RECRUITING
NCT05594901

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

Sponsor: University of Bologna

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

240

Start Date

2022-11-01

Completion Date

2025-06-30

Last Updated

2025-03-25

Healthy Volunteers

No

Interventions

OTHER

Application of a prognostic score

The CRECOOLT score, for the prospective cohort, will be systematically calculated once week, or at the occurrence of complications, until 60 days after OLT. The therapeutic management of all patients, during both retrospective and prospective periods, will be established by the attending physicians according with routine practice and not dictated by study protocol.

Locations (6)

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Università degli Studi di Padova - Unit Multivisceral Transplant Unit

Padova, Italy

Irccs Ismett

Palermo, Italy

ASST-Sette Laghi Università degli Studi dell'Insubria

Varese, Italy

Università degli Studi di Verona - Gastroenterologia

Verona, Italy

Hospital General Universitario Gregorio Maranon

Madrid, Spain