Prediction and Prevention of Bloodstream Infections After Kidney Transplantation

Condition(s) studied

Investigational drug(s) / intervention(s)

Pivmecillinam: Study participants in the intervention arm will receive 400 mg pivmecillinam tablets once daily administered orally. Treatment will be initiated one month post-transplantation and will continue for a total duration of 5 months (months 1-6 post-transplantation).

Placebo: Study participants in the placebo arm will receive one inactive placebo tablet once daily; the timing, frequency and duration is the same as for the active study drug.

Study summary

Kidney transplant recipients take medicines that suppress the immune system to prevent rejection of the transplanted kidney. As a result, they have a high risk of infections, especially urinary tract infections (UTIs). Some of these infections can spread to the bloodstream and cause serious illness, hospitalization, loss of kidney function, or death. Currently, there is no established strategy to prevent these serious bacterial infections in kidney transplant recipients who are at highest risk.

The PREDICT study is investigating whether a low daily dose of the antibiotic pivmecillinam can reduce the risk of bacterial urinary tract infections and bloodstream infections after kidney transplantation. The study focuses on kidney transplant recipients who have bacteria detected in their urine during the first month after transplantation, as previous research suggests that these patients have a particularly high risk of developing serious infections later.

In this randomized, double-blind, placebo-controlled trial, 180 adult kidney transplant recipients will be assigned by chance to receive either pivmecillinam or a matching placebo from 1 to 6 months after transplantation. Neither participants nor study staff will know which treatment has been assigned during the study. All participants will continue to receive standard post-transplant care and monitoring.

The main goal of the study is to determine whether prophylactic pivmecillinam can reduce the occurrence of infections caused by Enterobacterales bacteria, including urinary tract infections and bloodstream infections, during the first 6 months after transplantation. The study will also evaluate the effects of treatment on serious clinical outcomes, safety, quality of life, antimicrobial resistance, and long-term kidney transplant outcomes.

The study hypothesis is that targeted antibiotic prophylaxis with pivmecillinam in kidney transplant recipients at increased risk of infection will reduce the incidence of Enterobacterales urinary tract infections and bloodstream infections during the high-risk period after transplantation compared with placebo.

Eligibility

Primary outcome measure(s)

• Enterobacterales Urinary Tract Infections and/or Enterobacterales Bloodstream Infections — Months 1-6 post-transplantation
  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.

Trial sites (3)

More Susanne Dam Nielsen, MD, DMSc trials in Denmark

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