Prediction and Prevention of Bloodstream Infections After Kidney Transplantation

NCT07407673 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: PREDICT, EU 2026-527337-63-002026-527337-63-00
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Keywords

kidney transplantation; bloodstream infection; urinary tract infection; antibiotic prophylaxis; pivmecillinam; bacteriuria; Enterobacterales

Outcome Measures

Primary Outcomes (1)

• 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.

  Months 1-6 post-transplantation

Secondary Outcomes (13)

• Time to Enterobacterales Bloodstream Infection

  Months 1-6 post-transplantation

• Time to All-Cause Mortality

  Months 1-6 post-transplantation

• Time to First Hospital Admission

  Months 1-6 post-transplantation

• Time to Graft Loss

  Months 1-6 post-transplantation

• Time to ≥50% Decrease in eGFR From Baseline

  Months 1-6 post-transplantation

Other Outcomes (6)

• Exploratory: Change in Gut and Urinary Microbiome Diversity

  Months 1-6 post-transplantation

• Exploratory: Change in Gut and Urinary Resistome Diversity

  Months 1-6 post-transplantation

• Exploratory: Immunological and Metabolic Biomarkers

  Months 1-6 post-transplantation

Study Arms (2)

Pivmecillinam

ACTIVE COMPARATOR

The intervention group (n = 90) will receive pivmecillinam 400 mg once daily from months 1-6 post-transplantation

Drug: Pivmecillinam

Placebo

PLACEBO COMPARATOR

The placebo group (n = 90) will receive inactive placebo once daily from months 1-6 post-transplantation.

Drug: Placebo

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).

Pivmecillinam

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Susanne Dam Nielsen, MD, DMSc: lead

Study Sites (3)

Aarhus University Hospital, Department of Nephrology

Aarhus, 8200, Denmark

Location

Rigshospitalet, Department of Nephrology

Copenhagen, 2100, Denmark

Location

Odense University Hospital, Department of Nephrology

Odense, 5000, Denmark

Location

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MeSH Terms

Conditions

Sepsis; Infections; Urinary Tract Infections; Bacteriuria

Interventions

Amdinocillin Pivoxil

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amdinocillin; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Susanne D Poulsen, MD, dr.med.

CONTACT

0045 3545 0859; susanne.dam.poulsen@regionh.dk

Dina L Møller, MD, Ph.d

CONTACT

0045 2066 3942; dina.leth.moeller@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 12, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2041
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

DK (3)