NCT05594901

Brief 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.

Trial Health

58
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
3 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

October 12, 2022

Last Update Submit

March 24, 2025

Conditions

Liver TransplantationCarbapenem-Resistant Enterobacteriaceae Colonization

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to investigate the impact on all-cause 90-day mortality in OLT recipients colonized with CRE using the CRECOOLT score for the systematic evaluation of CRE infection risk.

    24 months

Secondary Outcomes (5)

  • 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.

    24 months

  • To evaluate rates of documented CRE infections and their relapses.

    24 months

  • To evaluate the length of hospital and ICU stay (days) in patients with and without systematic evaluation of CRE infection risk.

    24 months

  • To evaluate selection of further resistance in patients with documented CRE infection relapse with and without systematic evaluation of CRE infection risk.

    24 months

  • To evaluate rates of hospital readmission in patients with and without systematic evaluation of CRE infection risk.

    24 months

Study Arms (2)

Retrospective Cohort

Prospective Cohort

Other: Application of a prognostic score

Interventions

Application of a prognostic scoreOTHER

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.

Prospective Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

OLT recipients colonized by CRE

You may qualify if:

  • Signature of the informed consent
  • Age ≥ 18 years
  • CRE colonization within 60 days prior to or after transplantation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

São Paulo, Brazil

Location

Università degli Studi di Padova - Unit Multivisceral Transplant Unit

Padua, Italy

Location

Irccs Ismett

Palermo, Italy

Location

ASST-Sette Laghi Università degli Studi dell'Insubria

Varese, Italy

Location

Università degli Studi di Verona - Gastroenterologia

Verona, Italy

Location

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 26, 2022

Study Start

November 1, 2022

Primary Completion

October 31, 2024

Study Completion

June 30, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations

IT(4)ES(1)BR(1)