Targeted versus standard peri-operative prophylaxis in patients colonized with carbapenemase-producing Enterobacterales undergoing liver transplantation: a stepped-wedge cluster randomization trial

Condition studied

Patients colonized with CPE undergoing liver transplantation (LT)

Investigational medicinal product(s)

Every trial of Eravacycline, Aztreonam and Tigecycline across our registers →

Eligibility

Primary endpoint

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.

Endpoint detail

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).