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Clinical Trials in Spain / NCT05594901
Active, not recruiting Observational

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

NCT05594901 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Bologna
Phase
Observational
Started
2022-11-01
Last updated
2025-03-25

Condition(s) studied

Liver TransplantationCarbapenem-Resistant Enterobacteriaceae Colonization

Investigational drug(s) / intervention(s)

Application of a prognostic score

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Signature of the informed consent * Age ≥ 18 years * CRE colonization within 60 days prior to or after transplantation Exclusion Criteria: * Patients receiving targeted antibiotic prophylaxis (against CRE) for a period longer than 48 hours * Patients receiving graft from a donor with cultures yielding a carbapenem-resistant Gram negative bacteria

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05594901 on ClinicalTrials.gov ↗ ← All trials in Spain