NCT05594901|Completed
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Sponsor study identifier
observational
240
3 countries
6
Study Start
November 1, 2022
Actual (reported)Primary Completion
October 31, 2024
Actual (reported)Study Completion
June 30, 2025
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2022
Actual (reported)October 26, 2022
Actual (reported)November 1, 2022
Actual (reported)October 31, 2024
Actual (reported)June 30, 2025
Actual (reported)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
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
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.
OLT recipients colonized by CRE
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
240 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2022
First Posted
October 26, 2022
Study Start
November 1, 2022
Actual (reported)Transitional ePRO Diary Liver (Transitional-ePRO)
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Primary Completion
October 31, 2024
Actual (reported)Study Completion
June 30, 2025
Actual (reported)Last Updated
October 26, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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