Prediction and Prevention of Bloodstream Infections After Kidney Transplantation

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Kidney Transplant Infection, Bloodstream Infection, Kidney Transplant, Kidney Transplant Recipients, Infection, Urinary Tract Infection(UTI), Urinary Tract Infection Bacterial, Antibiotic Prophylaxis, Bacteriuria

In brief

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 facts

Study ID

NCT07407673

Run by

Susanne Dam Nielsen, MD, DMSc

People needed

180

Starts

2027-01-01

Expected to finish

2041-07-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Aarhus University Hospital, Department of Nephrology — Aarhus, Denmark
• Rigshospitalet, Department of Nephrology — Copenhagen, Denmark
• Odense University Hospital, Department of Nephrology — Odense, Denmark

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.