Efficacy of dalbavancin during osteo-articular infections associated with hip and knee prostheses

Phase 1

• Conditions: Osteo-articular infections; MedDRA version: 20.0Level: LLTClassification code 10075981Term: Staphylococcus aureus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-003169-20-FR
• Lead Sponsor: CHU de Nice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-22
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 43

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2.Tolerance of dalbavancin within 6 months of administration<br>3.Describe, at 12 and 24 months, the efficacy of dalbavancin in osteo-articular infections separately according to the germ involved, staphylococcus or streptococcus.<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Success is defined by the absence of failure within 24 months of surgery<br>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.<br>3.Describe at 12 and 24 months the success rate of treatment with dalbavancin according to microbiological data (in the staphylococcus and streptococcus subgroups).<br>4.Residual dosage of dalbavancin on D61;Timepoint(s) of evaluation of this end point: Within 24 months of surgery<br>Within 6 months of its first administration<br>12 and 24 months<br>Day 61