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Prediction and Prevention of Bloodstream Infections After Kidney Transplantation

Study acronym: PREDICT
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Jul 2029 → Jul 2031
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Susanne Dam Nielsen, MD, DMSc

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 2029 to Jul 2031v2 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: Phase 2 → Phase 3
    • Enrollment increased: 150 → 180 participants
    • Study completion pushed from Jul 2029 to Jul 2041
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: 5 to 13
    • Study description shortened, about 1,285 words
    • Study sites revised (3)
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07407673
Lead Sponsor Susanne Dam Nielsen, MD, DMSc
Conditions
(from sponsor)		 Kidney Transplant Infection, Bloodstream Infection, Kidney Transplant, Kidney Transplant Recipients, Infection, Urinary Tract Infection(UTI), Urinary Tract Infection Bacterial, Antibiotic Prophylaxis +1 more
Related terms Bacteriuria, Infections, Sepsis, Urinary Tract Infections
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov