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Study comparing dalbavancin to standard antibiotic treatment for patients with periprosthetic joint infection

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies the treatment of periprosthetic joint infection, which is an infection occurring around artificial joints in the knee, hip, or shoulder. The study compares two treatment approaches: a new antibiotic called dalbavancin versus standard antibiotic therapy. Standard antibiotics that may be used include amoxicillin, linezolid, flucloxacillin, gentamicin, vancomycin, and several others.

The main purpose of the study is to compare the costs and effectiveness of these treatments while also looking at how they affect patients' quality of life. The study will measure antibiotic levels in bone and tissue, track physical activity during treatment, and examine how the medications affect bacteria in the digestive system.

Treatment will last between 6 and 12 weeks, depending on the specific case. Patients will be monitored for up to one year to check for any complications or return of infection. During the study, participants will wear an activity tracker and complete questionnaires about their health and quality of life. Some participants will also provide tissue samples for laboratory analysis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase

    You will be assigned randomly to one of two treatment groups: either standard antibiotic therapy or dalbavancin treatment.

    The treatment is designed for patients with joint infections in the knee, hip, or shoulder artificial joints.

  2. Step 2

    Treatment period

    The treatment will last either 6 or 12 weeks, depending on your specific case.

    During this time, you will receive antibiotics according to your assigned group.

    You will wear an activity tracker to monitor your daily physical activity throughout the treatment period.

  3. Step 3

    Medical monitoring

    Your treatment will include regular checks of medication levels in your blood, bone tissue, and skin tissue.

    Samples will be taken to examine how the treatment affects your gut bacteria.

    Tissue samples will be analyzed to study your body's response to the infection and treatment.

  4. Step 4

    Quality of life assessment

    You will complete questionnaires about your quality of life during the treatment.

    These assessments help measure how the treatment affects your daily life and well-being.

  5. Step 5

    Follow-up period

    After completing the initial treatment, you will be monitored for one year.

    During this time, any complications or recurring infections will be documented.

    Final quality of life assessments will be conducted at the end of the follow-up period.

Who can join the trial?

7 criteria

  • You must be 18 years or older to participate
  • You must be able to provide signed informed consent forms showing you understand and agree to participate in the study
  • You must belong to one of these groups:
    • Have a suspected bacterial infection around your artificial joint (knee, hip, or shoulder) that needs surgical cleaning or replacement. This is called periprosthetic joint infection (PJI)
    • OR be scheduled for a planned knee replacement surgery
    • Both men and women can participate in this study
    • You must be able to complete questionnaires about your quality of life during the study
    • You must be willing to receive either standard antibiotic treatment or a medication called dalbavancin (which group you join will be decided randomly)

Who cannot join the trial?

15 criteria

  • Known allergy or hypersensitivity to dalbavancin or other similar antibiotics
  • Pregnancy or breastfeeding
  • Severe kidney problems (patients on dialysis or with severe renal impairment)
  • Active or ongoing liver disease (elevated liver enzymes more than 3 times the normal limit)
  • History of severe allergic reactions to medications
  • Currently participating in other clinical trials
  • Unable to provide informed consent
  • Serious heart conditions that are not well controlled
  • Active cancer treatment
  • Blood disorders that could affect treatment
  • Immunocompromised condition (weakened immune system)
  • History of previous adverse reactions to similar antibiotic treatments
  • Inability to follow up for the required study duration
  • Severe mental health conditions that could affect participation
  • Life expectancy less than the study duration
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Investigated drugs

Dalbavancin is an antibiotic medication used to treat serious bacterial infections. In this trial, it is being studied for treating infections that occur around joint replacements (prosthetic joints). It belongs to a class of antibiotics that work against Gram-positive bacteria. The medication is being evaluated as a potential alternative to standard antibiotic treatments, with a focus on its effectiveness in treating infections around artificial knees, hips, and shoulders. Standard antibiotic therapy (which may include various standard antibiotics) is the current conventional treatment for prosthetic joint infections. These are the established medications commonly used to treat bacterial infections around artificial joints. They serve as the comparison group in this study to evaluate the effectiveness and cost-efficiency of dalbavancin.

What is already known about the treatment

Dalbavancin – A long-acting intravenous antibiotic used to treat serious bacterial infections, particularly those caused by Gram-positive bacteria in periprosthetic joint infections. This medication belongs to the lipoglycopeptide class of antibiotics and works by interfering with bacterial cell wall synthesis, leading to bacterial cell death. Dalbavancin's unique feature is its extended half-life, which allows for less frequent dosing compared to standard antibiotics, potentially improving patient compliance and reducing hospital stays. The drug is currently being evaluated in clinical trials for its cost-effectiveness and impact on quality of life in patients with knee, hip, or shoulder joint infections, while also studying its concentration in bone tissue and effects on gut microbiota.

Investigated diseases

Periprosthetic Joint Infection - A serious complication that occurs when bacteria or other microorganisms grow in the area around artificial joint implants. The infection typically develops in the tissue and space around the artificial joint components, causing inflammation and damage to the surrounding tissue. The condition usually begins with symptoms such as pain, swelling, warmth around the joint, and limited mobility of the affected area. It can occur shortly after joint replacement surgery or develop years later, affecting hip, knee, or shoulder prosthetic joints. The infection can spread deeper into the tissue and potentially affect the bone surrounding the prosthesis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522088-13-00Protocol code32522Estimated enrolment50 patientsSponsorRegion Midtjylland

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