Osteo-articular infections MedDRA version: 20.0 Level: LLT Classification code 10075981 Term: Staphylococcus aureus infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: XYDALBA
Pharmaceutical Form: Powder for solution for infusion
Sponsors
CHU de Nice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged = 18 - osteo-articular infections of knee prosthesis or hip, monomicrobial, staphylococcus or streptococcus sensitive to dalbavancin (determined by an MIC by microdilution of the strain in question for vancomycin = 2mg/L) and rifampicin, treated surgically by DAIR with change of moving parts (acute infections) or change in 1 step (chronic infections) - Social security affiliation - Signature of informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - Hypersensibilité aux glycopeptides ou à la rifampicine ou à l’un des excipients - Porphyries - Traitement antibiotique probabiliste non administré dans les 24h suivant la chirurgie - Traitement antibiotique probabiliste n’ayant pas pris en considération dans son spectre la bactérie à l’origine de l’infection - Infection aiguë hématogène (secondaire aiguë) - Prise d’un traitement de fond incompatible avec l’effet inducteur de la rifampicine (cf RCP de la rifampicine) - Cirrhose hépatique - Prise de traitement ototoxique, comme un aminoside - Fonction rénale avec un débit de filtration glomérulaire mesuré par MDRD inférieur à 30 ml/min - Femmes enceintes et allaitantes - Personnes protégées définies dans les articles suivants du code de la santé publique : L. 1121-6 : personnes privées de liberté par une décision judiciaire ou administrative, personnes hospitalisées sans consentement et personnes admises dans un établissement sanitaire ou social à d’autres fins que celle de la recherche ; L. 1121-8 : personnes majeures faisant l’objet d’une mesure de protection légale ou hors d’état d’exprimer leur consentement ; L. 1122-1-2 : personnes en situations d’urgence ne pouvant pas donner un consentement préalable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Describe the efficacy of dalbavancin in combination with rifampicin in the treatment of staphylococcal or streptococcal osteo-articular infections associated with hip and knee prostheses 12 months after surgery.;Secondary Objective: 1.Describe the efficacy of dalbavancin in combination with rifampicin during the treatment of staphylococcal or streptococcal osteo-articular infections associated with hip and knee prostheses 24 months after surgery 2.Tolerance of dalbavancin within 6 months of administration 3.Describe, at 12 and 24 months, the efficacy of dalbavancin in osteo-articular infections separately according to the germ involved, staphylococcus or streptococcus. 4.Study of the association between residual dosage of dalbavancin at the end of treatment and clinical course at 12 and 24 months;Primary end point(s): Success is defined by the absence of failure within 12 months of surgery;Timepoint(s) of evaluation of this end point: within 12 months of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Success is defined by the absence of failure within 24 months of surgery 2. Tolerance will be assessed by collecting adverse reactions during treatment with dalbavancin and rifampicin classified according to the CTCAE (version 5.0) within 6 months of its first administration. 3. Describe at 12 and 24 months the success rate of treatment with dalbavancin according to microbiological data (in the staphylococcus and streptococcus subgroups). 4. Residual dosage of dalbavancin on D61;Timepoint(s) of evaluation of this end point: Within 24 months of surgery Within 6 months of its first administration 12 and 24 months Day 61 | — |
Countries
France
Contacts
Public ContactDRCI
CHU de Nice
Outcome results
None listed