DALBAVANCIN for Prosthetic joint infection | Staphylococcal infection

Inclusion criteria

• {"criterion_text":"- Age > or = 18 year old\n- Prosthetic joint infections of knee prosthesis, total hip prosthesis, intermediate hip prosthesis or total shoulder prosthesis (inverted or anatomical) monomicrobial with staphylococcus sensitive to dalbavancin (determined by MIC by microdilution of the strain in question for vancomycin < or = 2mg/L) and rifampicin, surgically treated with DAIR with or without changing moving parts (acute infections) or 1-stage or 2-stage change (chronic infections)\n- Social security affiliation"}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to glycopeptides or rifampicin or to any of the excipients\n- Fonction rénale avec un débit de filtration glomérulaire mesuré par COCKROFT inférieur à 30 ml/min\n- Pregnant and breast-feeding women: at inclusion, a blood pregnancy test will be performed for women of childbearing age. The results will be communicated to the patient by a physician of her choice.\n- Women of childbearing age not using an effective method of contraception (pill, intrauterine device, vaginal ring, contraceptive skin patch, hormonal subcutaneous implant, surgical sterilization).\n- Protected persons as defined in articles of the French Public Health Code.\n- Porphyria\n- probabilistic antibiotic treatment not administered within 24 hours of surgery\n- Probabilistic antibiotic treatment that does not take into account the bacterium causing the infection in its spectrum.\n- Acute blood-borne infection (acute secondary infection)\n- Use of background therapy incompatible with the inductive effect of rifampin (see rifampin SmPC).\n- Contraindications to rifampin therapy: Moderate to severe impairment of liver function, patients with a history of hypersensitivity to other rifamycins, porphyria.\n- Cirrhosis of the liver\n- Taking ototoxic treatments, such as aminoglycosides"}

Primary endpoints

• {"endpoint_text":"- Success is defined as the absence of failure within 12 months of surgical management.","definition_or_measurement_approach":"Success defined as the absence of failure within 12 months of surgical management (clinical outcome at 12 months post-surgery)."}

Secondary endpoints

• {"endpoint_text":"- Success is defined as the absence of failure within 24 months of surgical management.","definition_or_measurement_approach":"Success defined as the absence of failure within 24 months of surgical management (clinical outcome at 24 months post-surgery)."}
• {"endpoint_text":"- Tolerability will be assessed by collecting adverse events during treatment with dalbavancin and rifampicin classified according to CTCAE (version 5.0) within 6 months of first administration.","definition_or_measurement_approach":"Tolerability measured by collection and classification of adverse events according to CTCAE v5.0 within 6 months of first administration."}
• {"endpoint_text":"- Residual dose of dalbavancin at D61","definition_or_measurement_approach":"Measurement of residual dalbavancin concentration at day 61 (D61)."}

France

Earliest CTIS Part Ii Submission Date

07-10-2024

Latest Decision Or Authorization Date

08-08-2025

Processing Time Days

305

Number Of Sites

4

Number Of Participants

43

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nice

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France