Prediction and Prevention of Bloodstream Infections After Kidney Transplantation - the PREDICT Study

Bacterial urinary tract infections and bloodstream infections

Cumulative incidence of participants experiencing at least one Enterobacterales urinary tract infection and/or Enterobacterales bloodstream infection during months 1-6 post-transplantation, i.e., composite endpoint.

Time to first occurrence of any of the following events during months 1-6 post-transplantation (prioritized order): a) Enterobacterales bloodstream infection, b) all-cause mortality, c) hospital admission, d) graft loss, e) ≥50% decrease in graft function (eGFR) from baseline., Other infectious outcomes include urinary tract infections, and all bloodstream infections: a) Number of all Enterobacterales urinary tract infections during months 1-6 post-transplantation. b) Number of all urinary tract infections during months 1-6 post-transplantation c) Number of all bloodstream infections during months 1-6 post-transplantation., Proportion of participants experiencing at least one SAE and/or at least one AE of interest during months 1-6 post-transplantation, a) Proportion of participants experiencing at least one multidrug-resistant organism infection during months 1-6 post-transplantation, and number of infections with multidrug-resistant organisms b) Proportion of participants experiencing at least one Clostridium difficile infection during months 1-6 post-transplantation., Patient-reported quality of life (QoL) score at 6 months post-transplantation, assessed using the Forsberg et al. QoL psychometric for organ transplant recipients, Explorative endpoints: The following endpoints will be assessed separately: a) Microbiome: Change in microbial alpha diversity (richness, Shannon, Simpson, and Gini) and beta diversity from baseline (1 month post-transplantation) to 6 months post-transplantation. b) Resistome: Change in diversity of antibiotic resistance genes by type and subtype from baseline (1 month post-transplantation) to 6 months post-transplantation., Explorative endpoint: Changes in immunological and metabolic biomarkers measured in blood samples collected at baseline, 3 months, and 6 months post-transplantation. Analyses will include markers of systemic inflammation, immune activation, and metabolic function., Explorative endpoints: a) All-cause mortality determined at the 10-year registry follow-up. b) Risk of graft loss, determined at the 10-year registry follow-up. c) Risk of Enterobacterales bloodstream infection or any bloodstream infection, determined at the 10-year registry follow-up., Explorative endpoint: Distribution of antimicrobial susceptibility profiles, including pivmecillinam susceptibility.

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