MedTrace Logo

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

NCT05594901 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

  • Liver Transplantation
  • Carbapenem-Resistant Enterobacteriaceae Colonization

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.

Sponsors & Collaborators

  • The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

    collaborator OTHER

  • ASST-Sette Laghi Università degli Studi dell'Insubria Varese

    collaborator UNKNOWN

  • Università degli Studi di Padova Unit Multivisceral Transplant Unit Padova

    collaborator UNKNOWN

  • Università degli Studi di Verona - Gastroenterologia Verona

    collaborator UNKNOWN

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

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

    collaborator UNKNOWN

  • University of Bologna

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-10-31
Completion
2025-06-30

Countries

  • Brazil
  • Italy
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05594901 on ClinicalTrials.gov