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Prediction and Prevention of Bloodstream Infections After Kidney Transplantation

NCT07407673 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-12

No results posted yet for this study

Summary

Background: Kidney transplant (KTx) recipients receive life-long immunosuppression, which increases the risk of severe infections. Bloodstream infections (BSI) are common after transplantation and are associated with high mortality and morbidity. Prophylactic antibiotic treatment of all KTx recipients does not provide overall benefit, but a personalized strategy of prophylactic treatment of KTx recipients at high risk of BSI with targeted antibiotics has not been assessed.

Primary aim: To determine if prophylactic pivmecillinam in high-risk KTx recipients decreases the incidence of Enterobacterales BSI in the first 1-6 months post-transplantation.

Secondary aim: To assess if prophylactic pivmecillinam reduces all-cause mortality, hospital admissions, graft loss, changes in the gut and urine resistome and microbiome, and increases quality of life in high-risk KTx recipients.

Design and target group: Multi-center double-blinded randomized controlled trial of 150 KTx recipients at high risk of BSI who will be randomized 1:1 to either pivmecillinam 400 mg once daily or placebo from months 1-6 post-transplantation. KTx recipients will be included from Rigshospitalet, Aarhus University Hospital and Odense University Hospital. 60 participants in each study arm will provide urine and stool samples at randomization and at the end of intervention for metagenomic sequencing of the bacterial microbiome and resistome.

Perspectives: This trial will provide evidence necessary to assess if KTx recipients at high risk of BSI benefit from targeted prophylactic antibiotics and address a critical knowledge gap of how to reduce mortality and morbidity due to BSI after KTx. The study will also serve as proof-of-concept for a personalized approach to infection prevention in other populations at high risk of severe infections.

Results from the study may easily be implemented since there is already a clinical set-up for prevention of viral infections in KTx recipients.

Conditions

  • Kidney Transplant Infection
  • Bloodstream Infection

Interventions

DRUG

Pivmecillinam

The intervention group will receive pivmecillinam 400 mg once daily from months 1-6 post-transplantation.

DRUG

Placebo

The control group (n=75) will receive placebo once daily from months 1-6 post-transplantation.

Sponsors & Collaborators

  • Susanne Dam Nielsen, MD, DMSc

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2029-07-31
Completion
2029-07-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07407673 on ClinicalTrials.gov