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NCT05594901
Impact of a Risk Stratification Tool on the Outcome of Liver Transplant Recipients Colonized With Carbapenem Resistant Enterobacteriaceae: an Observational Study
trial testing Application of a prognostic score in Liver Transplantation in 240 participants. Participants enrolled and being followed up; not accepting new ones.
31 October 2024
Quick facts
| Lead sponsor | University of Bologna |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 240 |
| Start date | 1 November 2022 |
| Primary completion | 31 October 2024 |
| Estimated completion | 30 June 2025 |
| Sites | 6 locations across Italy, Spain, Brazil |
Drugs / interventions tested
- Application of a prognostic score
Conditions studied
- Liver Transplantation — all drugs for Liver Transplantation →
- Carbapenem-Resistant Enterobacteriaceae Colonization — all drugs for Carbapenem-Resistant Enterobacteriaceae Colonization →
Sponsor
University of Bologna
Who can join
18 and older, any sex, with Liver Transplantation or Carbapenem-Resistant Enterobacteriaceae Colonization. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05594901
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05594901 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Bologna
- Last refreshed: 25 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05594901.
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