Patients colonized with CPE undergoing liver transplantation (LT)
Conditions
Brief summary
The treatment effect of T-PAP over S-PAP is intended as a reduced CPE infection rate in the first two weeks after LT in the intervention with respect to the control group.
Detailed description
The dynamics of gut microbiome will be assessed evaluating differences in diversity, composition at different taxonomic levels and functionality between and within groups over time, at the time of LT, and at 14, 30, 60 and 90 days after LT., The occurrence of any CPE and non-CPE infection within 14 days from LT in relation to optimal PK/PD attainment in patients colonized with CPE will be assessed as described in paragraph 3.3 for the primary endpoint., CPE carriage status, development of any type of bacterial infections and all-cause mortality, will be assessed at 30, 60 and 90 days from the date of LT both singularly and as a composite defined as: no events (discharged and decolonized); discharged and not decolonized; discharged and infected; still hospitalized or readmitted with infection; died., Endpoint for safety is an adverse event potentially related to the study drugs (e.g. neurotoxicity, nephrotoxicity, immediate and delayed hypersensitivity manifestations) occurring during prophylaxis administration or within 7 days from the initiation of administration (delayed hypersensitivity reactions).
Interventions
DRUGXerava 50 mg powder for concentrate for solution for infusion
DRUGRecarbrio 500 mg/500 mg/250 mg powder for solution for infusion
DRUGEmblaveo 1.5 g/0.5 g powder for concentrate for solution for infusion
DRUGTygacil 50 mg powder for solution for infusion
DRUGAMOXICILLINA E ACIDO CLAVULANICO SANDOZ A/S 2000 mg/200 mg polvere per soluzione per infusione
DRUGTazocin® 4 g / 0.5 g powder for solution for infusion
Sponsors
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The treatment effect of T-PAP over S-PAP is intended as a reduced CPE infection rate in the first two weeks after LT in the intervention with respect to the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The dynamics of gut microbiome will be assessed evaluating differences in diversity, composition at different taxonomic levels and functionality between and within groups over time, at the time of LT, and at 14, 30, 60 and 90 days after LT., The occurrence of any CPE and non-CPE infection within 14 days from LT in relation to optimal PK/PD attainment in patients colonized with CPE will be assessed as described in paragraph 3.3 for the primary endpoint., CPE carriage status, development of any type of bacterial infections and all-cause mortality, will be assessed at 30, 60 and 90 days from the date of LT both singularly and as a composite defined as: no events (discharged and decolonized); discharged and not decolonized; discharged and infected; still hospitalized or readmitted with infection; died., Endpoint for safety is an adverse event potentially related to the study drugs (e.g. neurotoxicity, nephrotoxicity, immediate and delayed hypersensitivity manifestations) occurring during p | — |
Outcome results
None listed