Prediction and Prevention of Bloodstream Infections After Kidney Transplantation

NCT07407673 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Sponser - Rigshopitalet
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Prevention of bloodstream infection after kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Enterobacterales bloodstream infections

  Proportion of participants with one or more Enterobacterales bloodstream infections during the first 6-12 month post-transplantation in the treatment arm vs. the placebo arm. Scale numeric from 0-100% (higher proportion is worser)

  The first 1-6 months post-transplantation

Secondary Outcomes (5)

• Severe outcome

  The first 1-6 months post-transplantation

• Infectious outcomes

  The first 1-6 months post-transplantation

• Outcomes related to the use of antibiotics

  The first 1-6 months post-transplantation

• Serious adverse events

  The first 1-6 months post-transplantation

• Patient-related outcomes

  The first 1-6 months post-transplantation

Other Outcomes (1)

• Microbiome and resistome

  At 1, 3 and 6 month post-transplantation

Study Arms (2)

Intervention

ACTIVE COMPARATOR

The intervention group (n=75) will receive pivmecillinam 400 mg once daily from months 1-6 post-transplantation

Drug: Pivmecillinam

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Pivmecillinam DRUG

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

Intervention

Placebo DRUG

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

Control

Eligibility Criteria

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

You may qualify if:

• Adult (\>18 years) KTx recipients at high risk of BSI in the first year post-KTx.
• Recipients at high risk of BSI will be defined as recipients belonging to a group with a predicted BSI incidence of 25% in the first year post-transplantation by the prediction model.

You may not qualify if:

• Recipients who cannot give informed consent or have contraindications for pivmecillinam treatment, including allergy to beta-lactamase antibiotics.

Sponsors & Collaborators

• Susanne Dam Nielsen, MD, DMSc: lead

Study Sites (3)

Aarhus University Hospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

Sepsis

Interventions

Amdinocillin Pivoxil

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 2
• 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, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

DK (3)