A Phase 3 interventional study of Pivmecillinam and Placebo in Kidney Transplant Infection, Bloodstream Infection and Kidney Transplant, sponsored by Susanne Dam Nielsen, MD, DMSc. Not yet recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Susanne Dam Nielsen, MD, DMSc · Phase 3, Interventional, and Prevention
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 includes 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 later serious infections.
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 main 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.
Background:
Kidney transplant recipients are at increased risk of infectious complications, in part because of immunosuppressive treatment 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 the burden of infections, there is currently no established targeted strategy to prevent serious bacterial infections in kidney transplant recipients.
Previous work by the investigators has 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 suitable 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 incidence of Enterobacterales urinary tract infections and/or bloodstream infections in high-risk kidney transplant recipients.
Secondary objectives include evaluation of all bloodstream and urinary tract infections, severe clinical outcomes, treatment safety, infections with multidrug-resistant organisms or Clostridioides difficile, and patient-reported quality of life.
Exploratory objectives include investigation of the distribution of urine antimicrobial susceptibility profiles, changes in the gut and urinary microbiome and resistome, changes in 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. Ten-year long-term outcomes will be assessed through national registry follow-up.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 180 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Susanne Dam Nielsen, MD, DMSc is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group (n = 90) will receive pivmecillinam 400 mg once daily from months 1-6 post-transplantation
Drug: Pivmecillinam
The placebo group (n = 90) will receive inactive placebo once daily from months 1-6 post-transplantation.
Drug: Placebo
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).
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.
Enterobacterales Urinary Tract Infections and/or Enterobacterales 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 frame: Months 1-6 post-transplantation
Time to Enterobacterales Bloodstream Infection
Time to first occurrence of Enterobacterales bloodstream infection during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Time to All-Cause Mortality
Time to death of any cause during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Time to First Hospital Admission
Time to first hospital admission during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Time to Graft Loss
Time to graft loss during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Time to ≥50% Decrease in eGFR From Baseline
Time to first occurence of a ≥50% decrease in eGFR from baseline during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Time to Severe Clinical Outcome
Time to first occurrence of severe clinical outcome during months 1-6 post-transplantation, i.e., composite endpoint of time to first Enterobacterales bloodstream infection, to death of any cause, to first hospital admission, to graft loss, or to first occurence of a ≥50% decrease in eGFR from baseline
Time frame: Months 1-6 post-transplantation
Proportion of Participants with Severe Clinical Outcome
Proportion of participants with severe clinical outcome during months 1-6 post-transplantation, i.e., composite endpoint of Enterobacterales bloodstream infection, death of any cause, hospital admission, graft loss, ≥50% decrease in eGFR from baseline
Time frame: Months 1-6 post-transplantation
Number of Enterobacterales Urinary Tract Infections
Number of Enterobacterales urinary tract infections during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Number of All Urinary Tract Infections
Number of all urinary tract infections during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Number of All Bloodstream Infections
Number of all bloodstream infections during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Participants Experiencing at Least One Serious Adverse Event and/or Adverse Event of Interest
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.
Time frame: Months 1-6 post-transplantation
Participants Experiencing at Least One Multidrug-Resistant Organism Infection
Proportion of participants experiencing at least one multidrug-resistant organism infection during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Number of Multidrug-Resistant Organism Infections
Number of multidrug-resistant organism infections during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Participants Experiencing at Least One Clostridioides difficile Infection
Proportion of participants experiencing at least one Clostridioides difficile infection during months 1-6 post-transplantation
Time frame: Months 1-6 post-transplantation
Patient-reported quality of life
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
Time frame: Months 1-6 post-transplantation
Exploratory: Changes in Antimicrobial susceptibility patterns in urine isolates
Changes in distribution of antimicrobial susceptibility profiles in urine isolates, including pivmecillinam susceptibility
Time frame: Months 1-6 post-transplantation
Exploratory: Change in Gut and Urinary Microbiome Diversity
Change in microbial alpha diversity (richness, Shannon, Simpson, and Gini) and beta diversity from baseline (1 month post-transplantation) to 6 months post-transplantation
Time frame: Months 1-6 post-transplantation
Exploratory: Change in Gut and Urinary Resistome Diversity
Change in diversity of antibiotic resistance genes by type and subtype from baseline (1 month post-transplantation) to 6 months post-transplantation
Time frame: Months 1-6 post-transplantation
Exploratory: Immunological and Metabolic Biomarkers
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
Time frame: Months 1-6 post-transplantation
Exploratory: Long-Term All-Cause Mortality
All-cause mortality determined at the 10-year registry follow-up
Time frame: 10 years after study treatment completion
Exploratory: Long-Term Risk of Graft Loss
Graft loss determined at the 10-year registry follow-up
Time frame: 10 years after study treatment completion
Exploratory: Long-Term Risk of Bloodstream Infections
Any bloodstream infection determined at the 10-year registry follow-up
Time frame: 10 years after study treatment completion
Plan to share: Undecided
Start is estimated for Jan 2027; primary completion for Jul 2031, 54 months later.
Of 58 non-industry phase 3 interventional studies under Sepsis, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 68. This study's planned 54 months is above that.
Counting every sponsor, half of 66 studies reached it within 39 months; a quarter within 24 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Susanne Dam Nielsen, MD, DMSc