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Study on Dalbavancin and Rifampicin for Treating Prosthetic Joint Infections in Patients with Hip, Knee, and Shoulder Replacements

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 is focused on studying the effectiveness of a treatment for prosthetic joint infections, which are infections that occur in artificial joints like those in the hip, knee, or shoulder. The treatment being tested combines two medications: dalbavancin and rifampicin. Dalbavancin is given as a solution through an infusion, which means it is delivered directly into the bloodstream, while rifampicin is taken orally in capsule form. These medications are being used together to see how well they work in treating infections caused by bacteria, specifically those sensitive to these drugs.

The purpose of the study is to evaluate how effective this combination treatment is in managing infections associated with joint prostheses over a period of 12 months after surgery. Participants in the study will receive the treatment and be monitored for any signs of the infection returning or not improving. The study will also look at how well patients tolerate the medications by checking for any side effects during the treatment period.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on the success of the treatment. The main goal is to determine if the combination of dalbavancin and rifampicin can effectively prevent the failure of the treatment within a year after surgical management of the infection. Additionally, the study will assess the treatment's success over a longer period of 24 months and monitor any adverse effects experienced by the participants.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as being 18 years or older and having a prosthetic joint infection in the hip, knee, or shoulder.

    The infection must be caused by a specific type of bacteria that is sensitive to the medications used in the study.

  2. Step 2

    Initial treatment phase

    The treatment involves the use of two medications: dalbavancin and rifampicin.

    Dalbavancin is administered as an infusion, which means it is given directly into the bloodstream through a vein.

    Rifampicin is taken orally, meaning it is swallowed in the form of a pill or liquid.

  3. Step 3

    Medication schedule

    The exact dosage and frequency of the medications will be determined by the healthcare team based on individual needs.

    The treatment duration is planned to be monitored over a period of 12 months following surgical management.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up appointments will be scheduled to monitor the effectiveness of the treatment and any potential side effects.

    Success is defined as the absence of infection failure within 12 months after surgical management.

  5. Step 5

    Extended observation

    Further observation may continue up to 24 months to ensure long-term success of the treatment.

    Tolerability of the medications will be assessed by collecting information on any adverse events during the treatment period.

  6. Step 6

    Final assessment

    A final assessment will be conducted to evaluate the overall success of the treatment and the patient's recovery.

    The study aims to ensure that the infection does not return and that the patient experiences minimal side effects from the medications.

Who can join the trial?

6 criteria

  • Must be 18 years old or older.
  • Have a prosthetic joint infection in the knee, hip, or shoulder. This means an infection in an artificial joint.
  • The infection must be caused by a type of bacteria called staphylococcus that is sensitive to the antibiotics dalbavancin and rifampicin. Sensitivity means that these antibiotics can effectively treat the infection.
  • The infection must have been treated surgically. This could include:
    • DAIR (Debridement, Antibiotics, and Implant Retention) with or without changing the moving parts of the joint for acute infections. Acute infections are those that occur suddenly and are severe.
    • A 1-stage or 2-stage change for chronic infections. Chronic infections are long-lasting and may require more complex treatment.
    • Must have social security affiliation. This means being registered with a social security system.

Who cannot join the trial?

3 criteria

  • Patients with **prosthetic joint infections** cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

  • Dalbavancin

    is an antibiotic used to treat serious infections caused by bacteria. In this clinical trial, it is being tested for its effectiveness in treating infections that occur in the joints, particularly those associated with hip, knee, and shoulder prostheses. The goal is to see how well dalbavancin works in combination with another medication to fight these infections over a period of 12 months after surgery.

  • Rifampicin

    is another antibiotic that is often used to treat various bacterial infections. In this trial, it is used alongside dalbavancin to help treat infections caused by staphylococcal bacteria in patients who have had joint replacement surgeries. The combination of these two antibiotics aims to improve the treatment outcomes for patients with these types of infections.

What is already known about the treatment

Dalbavancin – Dalbavancin is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently being studied for its effectiveness in treating infections related to prosthetic joints, such as those in the hip, knee, and shoulder. The main therapeutic use of dalbavancin in this context is to combat infections caused by staphylococcal bacteria. At the molecular level, dalbavancin works by interfering with the bacteria's ability to build their cell walls, which is essential for their survival. It belongs to a class of drugs known as lipoglycopeptide antibiotics.

Investigated diseases

Prosthetic Joint Infections – Prosthetic joint infections occur when bacteria or other microorganisms infect the area around an artificial joint, such as a hip, knee, or shoulder replacement. These infections can develop shortly after surgery or even years later. The infection typically causes pain, swelling, and redness around the joint, and may lead to the loosening of the prosthetic device. As the infection progresses, it can cause joint stiffness and reduced mobility. In severe cases, the infection may spread to surrounding tissues and bones. The progression of the disease can vary depending on the type of bacteria involved and the patient's overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518183-12-00Protocol code20-AOI-03Estimated enrolment43 patientsSponsorCentre Hospitalier Universitaire De Nice

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