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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier De Tourcoing	Tourcoing	France
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Cususv Hjboivzsnuo Rdjphzlr Uympxxhygxvkn Du Tgrpo	Tours	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	07.03.2022

Trial locations

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.

Investigated diseases:

Staphylococcal infection

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 ID:

2024-518183-12-00

Protocol code:

20-AOI-03

NCT ID:

NCT05046860

Trial Phase:

Therapeutic use (Phase IV)

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

What is this study about?

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