Efficacy of Dalbavancin and Rifampicin in Treating Staphylococcal Prosthetic Joint Infections in Hip, Knee, and Shoulder Prostheses

The primary objective of this study is to describe the **efficacy** of dalbavancin in combination with rifampicin during the treatment of staphylococcal healthcare-associated infections (HAIs) associated with hip, knee, and shoulder prostheses, evaluated 12 months after surgical management. This is clinically relevant as it addresses the challenge of managing prosthetic joint infections, which are often difficult to treat and can lead to significant morbidity.

Secondary objectives include:

• Describing the efficacy of dalbavancin in combination with rifampicin in the treatment of staphylococcal HAIs associated with hip, knee, and shoulder prostheses 24 months after surgical management.
• Assessing the tolerance of dalbavancin in the 6 months following administration.
• Studying the association between residual dalbavancin dosage at the end of treatment and clinical outcome at 12 and 24 months.
• Documenting the signature of informed consent.

The clinical trial focuses on individuals diagnosed with **prosthetic joint infections** associated with hip, knee, and shoulder prostheses. The study population includes both male and female participants aged 18 years and older. Participants are required to have monomicrobial infections with staphylococcus sensitive to dalbavancin and rifampicin, and must have undergone surgical treatment. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants' general health status is not specified, and no specific lifestyle considerations such as diet or physical activity are mentioned. Key inclusion criteria include having a prosthetic joint infection and being affiliated with social security. The selection process for the trial population is not detailed in the provided data.

The clinical trial is designed to evaluate the **efficacy** of **dalbavancin** in combination with **rifampicin** for the treatment of **prosthetic joint infections** associated with hip, knee, and shoulder prostheses. This study employs a randomized, double-blind, controlled trial design to ensure the reliability and validity of the results. The trial is expected to span a duration from March 2022 to January 2027, with participant involvement lasting up to 12 months post-surgical management.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (≥18 years), specific prosthetic joint infections, and social security affiliation. Following the screening, participants will receive treatment and be monitored through regular follow-up visits to assess the primary endpoint, defined as the absence of failure within 12 months of surgical management. Secondary endpoints include the absence of failure within 24 months, assessment of tolerability through adverse event collection, and measurement of residual **dalbavancin** dose at day 61.

The end-of-study visit will conclude the participant's involvement, provided there are no conditions necessitating early termination, such as adverse reactions or withdrawal of consent. Participants may be removed from the study if they experience significant adverse events or if they fail to comply with the study protocol. The trial aims to provide comprehensive data on the treatment's efficacy and safety, contributing valuable insights into the management of **staphylococcal** infections in prosthetic joints.

The clinical trial involves the administration of two **experimental medications**: **Rifampicin** and **Dalbavancin**. **Rifampicin** is provided in a **capsule** form and is administered **orally**. The maximum daily dose of **Rifampicin** is 900 mg, with a total maximum dose of 75,600 mg over a treatment period of up to 12 months. This medication is classified as an **antibiotic** and is utilized in the study to evaluate its efficacy in combination with **Dalbavancin** for the treatment of staphylococcal healthcare-associated infections (HAIs) associated with hip, knee, and shoulder prostheses.

**Dalbavancin** is supplied as a **powder for concentrate for solution for infusion**. It is administered via **infusion** with a maximum daily dose of 15 mg/l and a total maximum dose of 75 mg/l over a treatment period of up to 5 days. The product is manufactured by **ABBVIE DEUTSCHLAND GMBH & CO. KG** and is also classified as an **antibiotic**. The study aims to assess the efficacy of **Dalbavancin** in combination with **Rifampicin** in the specified infections. Participant compliance with the dosing schedule will be monitored throughout the trial to ensure adherence to the treatment regimen.

The clinical trial aims to assess the efficacy of **dalbavancin** in combination with **rifampicin** for the treatment of staphylococcal healthcare-associated infections (HAIs) associated with hip, knee, and shoulder prostheses. The primary endpoint for evaluating efficacy is defined as the absence of failure within 12 months following surgical management. Secondary endpoints include the absence of failure within 24 months post-surgical management, assessment of tolerability through the collection of adverse events during treatment, classified according to CTCAE version 5.0 within 6 months of the first administration, and the measurement of the residual dose of dalbavancin at day 61.

Efficacy parameters will be collected and analyzed at specified timepoints, with the primary endpoint being assessed at 12 months and secondary endpoints at 24 months. Tolerability will be monitored throughout the treatment period, and adverse events will be documented and classified. The trial will utilize validated methods for measuring these parameters to ensure accuracy and reliability in the assessment of the treatment's efficacy.