Prediction and Prevention of Bloodstream Infections After Kidney Transplantation (PREDICT)

July 20, 2026 updated by: Susanne Dam Nielsen, MD, DMSc

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Kidney transplant recipients are at increased risk of infectious complications because immunosuppressive treatment is required to prevent rejection of the transplanted kidney. Urinary tract infections are among the most common infectious complications after transplantation and may lead to bloodstream infections, which are associated with substantial morbidity, mortality, and risk of graft loss. Despite this burden, there is currently no established targeted strategy to prevent serious bacterial infections in kidney transplant recipients at highest risk of infection.

Previous work by the investigators demonstrated that bacteriuria during the first month after kidney transplantation is an important predictor of subsequent urinary tract infections and bloodstream infections. Early bacteriuria therefore represents a clinically useful marker for identifying a high-risk subgroup that may benefit from preventive interventions.

Study rationale:

The PREDICT study evaluates a risk-stratified prophylactic strategy using pivmecillinam in kidney transplant recipients with early bacteriuria. Pivmecillinam is a narrow-spectrum oral antibiotic with activity against Enterobacterales, which are the predominant causes of urinary tract infections and bloodstream infections after kidney transplantation. Its pharmacological profile and extensive clinical experience make it a potential candidate for targeted prevention during the period of highest infection risk after transplantation.

Objectives:

The primary objective is to determine whether prophylactic pivmecillinam reduces the occurrence of Enterobacterales urinary tract infections and/or bloodstream infections in high-risk kidney transplant recipients. Secondary objectives include evaluation of all bloodstream infections, severe clinical outcomes, treatment safety, antimicrobial resistance, and patient-reported quality of life. Exploratory objectives include investigation of microbiome and resistome changes, immunological and metabolic biomarkers, and long-term transplant outcomes.

Study Design:

PREDICT is a Danish nationwide multicentre randomized, double-blind, placebo-controlled trial. Adult kidney transplant recipients with bacteriuria during the first month after transplantation will be randomly assigned to receive prophylactic pivmecillinam or placebo in addition to standard post-transplant care. Participants will be followed during the intervention period and for safety evaluation after treatment completion. Long-term outcomes will be assessed through national registry follow-up.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital, Department of Nephrology
        • Contact:
        • Principal Investigator:
          • Henrik Birn, MD, PhD, dr.med.
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, Department of Nephrology
        • Contact:
        • Principal Investigator:
          • Morten B Jørgensen, MD, PhD
      • Odense, Denmark, 5000
        • Odense University Hospital, Department of Nephrology
        • Contact:
        • Principal Investigator:
          • Claus Bistrup, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years.
  2. Kidney transplant recipient.
  3. Able to provide written informed consent.
  4. ≥1 urine sample with bacteriuria ≥10^5 CFU/mL (excluding fungi) within first month post-transplantation.

Exclusion Criteria:

  1. Known strictures in the esophagus and/or obstructions in the gastrointestinal tract including diabetes gastroparesis.
  2. Known hypersensitivity or allergy to β-lactam antibiotics.
  3. Known or suspected genetic metabolism anomalies in the carnitine metabolism, including carnitine transporter defect or organic acidurias such as methylmalonic aciduria or propionic acidaemia.
  4. Individuals of Faroese descent (defined as both biological parents born in the Faroe Islands).
  5. Porphyria.
  6. Current treatment with valproic acid, valproate or other medications liberating pivalic acid.
  7. Current treatment with probenecid.
  8. Current treatment with methotrexate.
  9. Ongoing dialysis one month post-transplantation.
  10. Pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pivmecillinam
The intervention group (n = 90) will receive pivmecillinam 400 mg once daily from months 1-6 post-transplantation
Drug: 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 Comparator: Placebo
The placebo group (n = 90) will receive inactive placebo once daily from months 1-6 post-transplantation.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enterobacterales Urinary Tract Infections and/or Enterobacterales Bloodstream Infections
Time Frame: 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.
Months 1-6 post-transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Enterobacterales Bloodstream Infection
Time Frame: Months 1-6 post-transplantation
Time to first occurrence of Enterobacterales bloodstream infection during months 1-6 post-transplantation
Months 1-6 post-transplantation
Time to All-Cause Mortality
Time Frame: Months 1-6 post-transplantation
Time to death of any cause during months 1-6 post-transplantation
Months 1-6 post-transplantation
Time to First Hospital Admission
Time Frame: Months 1-6 post-transplantation
Time to first hospital admission during months 1-6 post-transplantation
Months 1-6 post-transplantation
Time to Graft Loss
Time Frame: Months 1-6 post-transplantation
Time to graft loss during months 1-6 post-transplantation
Months 1-6 post-transplantation
Time to ≥50% Decrease in eGFR From Baseline
Time Frame: Months 1-6 post-transplantation
Time to first occurence of a ≥50% decrease in eGFR from baseline during months 1-6 post-transplantation
Months 1-6 post-transplantation
Number of Enterobacterales Urinary Tract Infections
Time Frame: Months 1-6 post-transplantation
Number of Enterobacterales urinary tract infections during months 1-6 post-transplantation
Months 1-6 post-transplantation
Number of All Urinary Tract Infections
Time Frame: Months 1-6 post-transplantation
Number of all urinary tract infections during months 1-6 post-transplantation
Months 1-6 post-transplantation
Number of All Bloodstream Infections
Time Frame: Months 1-6 post-transplantation
Number of all bloodstream infections during months 1-6 post-transplantation
Months 1-6 post-transplantation
Participants Experiencing at Least One Serious Adverse Event and/or Adverse Event of Interest
Time Frame: Months 1-6 post-transplantation
Proportion of participants experiencing at least one serious adverse event and/or at least one adverse event of interest during months 1-6 post-transplantation.
Months 1-6 post-transplantation
Participants Experiencing at Least One Multidrug-Resistant Organism Infection
Time Frame: Months 1-6 post-transplantation
Proportion of participants experiencing at least one multidrug-resistant organism infection during months 1-6 post-transplantation.
Months 1-6 post-transplantation
Number of Multidrug-Resistant Organism Infections
Time Frame: Months 1-6 post-transplantation
Number of multidrug-resistant organism infections during months 1-6 post-transplantation
Months 1-6 post-transplantation
Participants Experiencing at Least One Clostridioides difficile Infection
Time Frame: Months 1-6 post-transplantation
Proportion of participants experiencing at least one Clostridioides difficile infection during months 1-6 post-transplantation
Months 1-6 post-transplantation
Patient-reported quality of life
Time Frame: Months 1-6 post-transplantation
Patient-reported quality of life assessed 6 months post-transplantation using the Quality of Life Instrument for Solid Organ Transplant Recipients (OTSWI; Forsberg et al., 2012). Total scores range from 0 to 160, with lower scores indicating better quality of life
Months 1-6 post-transplantation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory: Change in Gut and Urinary Microbiome Diversity
Time Frame: Months 1-6 post-transplantation
Change in microbial alpha diversity (richness, Shannon, Simpson, and Gini) and beta diversity from baseline (1 month post-transplantation) to 6 months post-transplantation.
Months 1-6 post-transplantation
Exploratory: Change in Gut and Urinary Resistome Diversity
Time Frame: Months 1-6 post-transplantation
Change in diversity of antibiotic resistance genes by type and subtype from baseline (1 month post-transplantation) to 6 months post-transplantation.
Months 1-6 post-transplantation
Exploratory: Immunological and Metabolic Biomarkers
Time Frame: Months 1-6 post-transplantation
Exploratory analyses of immunological and metabolic biomarkers measured in blood samples collected at baseline, 3 months, and 6 months post-transplantation to investigate potential associations with systemic inflammation, immune activation, and metabolic function.
Months 1-6 post-transplantation
Exploratory: Long-Term All-Cause Mortality
Time Frame: 10 years after study treatment completion
All-cause mortality determined at the 10-year registry follow-up
10 years after study treatment completion
Exploratory: Long-Term Risk of Graft Loss
Time Frame: 10 years after study treatment completion
Graft loss determined at the 10-year registry follow-up
10 years after study treatment completion
Exploratory: Long-Term Risk of Bloodstream Infections
Time Frame: 10 years after study treatment completion
Any bloodstream infection determined at the 10-year registry follow-up.
10 years after study treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Susanne Dam Nielsen, MD, DMSc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2041

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDICT, EU 2026-527337-63-00
  • 2026-527337-63-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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