Prediction and Prevention of Bloodstream Infections After Kidney Transplantation

Sponsor
Susanne Dam Nielsen, MD, DMSc
Study ID
NCT07407673
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Antibiotic Prophylaxis
  • Bacteriuria
  • Bloodstream Infection
  • Infection
  • Kidney Transplant
  • Kidney Transplant Infection
  • Kidney Transplant Recipients
  • Urinary Tract Infection Bacterial
  • Urinary Tract Infection(UTI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pivmecillinam — DRUG
    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 — DRUG
    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 Details

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.

Key Dates

First listed
Feb 12, 2026
Start date
Jan 1, 2027
Status verified
Jul 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2041

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Pivmecillinam
    The intervention group (n = 90) will receive pivmecillinam 400 mg once daily from months 1-6 post-transplantation
  • Placebo Comparator: Placebo
    The placebo group (n = 90) will receive inactive placebo once daily from months 1-6 post-transplantation.

Primary Outcome Measure

Enterobacterales Urinary Tract Infections and/or Enterobacterales Bloodstream Infections [ Time Frame: Months 1-6 post-transplantation ]

Central Contacts

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