Teicoplanin-based Antimicrobial Therapy in Staphylococcus Aureus Bone and Joint Infection: Tolerance, Efficacy and Experience With Subcutaneous Administration

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT03177369

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Staphylococci represent the first etiologic agents of bone and joint infection (BJI), leading glycopeptides use, especially in case of methicillin-resistance or betalactam intolerance. Teicoplanin may represent an alternative to vancomycin because of its acceptable bone penetration and possible subcutaneous administration. Various studies have shown that teicoplanin pharmacodynamic profile was superior compared to vancomycin regarding bone diffusion. Few studies have investigated the use of teicoplanin in BJI, particularly through subcutaneous administration.

The aim of this study assesses the efficacy and tolerance of teicoplanin in S. aureus BJI, especially focusing on subcutaneous use. This study is a retrospective single-center observational cohort study (2001 to 2011) including all consecutive patients managed at our institution receiving teicoplanin as part of S. aureus BJI treatment.

Condition or Disease	Intervention/Treatment	Phase
Teicoplanin-based Antimicrobial Therapy Staphylococcus Aureus Bone and Joint Infection

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Teicoplanin-based Antimicrobial Therapy in Staphylococcus Aureus Bone and Joint Infection: Tolerance, Efficacy and Experience With Subcutaneous Administration

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Outcome Measures

Primary Outcome Measures

Efficacy of teicoplanin in S.aureus bone and joint infection [90 weeks]
The median total duration of follow-up is 90 weeks. Outcome of patients having had teicoplanin is described in this part. Treatment failure is defined as persisting infection under appropriate antimicrobial therapy, relapse after the interruption of antimicrobial therapy, necessity of surgical revision on the account of persisting septic focus ≥5 days after the first intervention, superinfections, and/or fatal outcome if BJI-related. The results obtained with IV or SC administration are compared.

Secondary Outcome Measures

Tolerance of teicoplanin in S.aureus bone and joint infection [6 weeks]
The median total duration of teicoplanin therapy is 6 weeks (IV or SC). Teicoplanin-related adverse events (AE) occurring during follow-up are notified and classified according to the Common Terminology Criteria for Adverse Events (CTCAE, National Cancer Institute, 2003). Teicoplanin accountability in the AE occurrence is left to the clinician appreciation, with the help of a pharmacovigilance specialist in doubtful cases. The results obtained with IV or SC administration are compared.
Pharmacocinetiks characteristics : Cmin value [2 weeks]
During the first 14 days of treatment, at least one Cmin value is available. A Cmin >15 mg/L is taken as an acceptable therapeutic target. Patients with a Cmin >25 mg/L is considered as overexposure. (The results for overexposure and Cmin under the therapeutic target are compared for IV and SC administration.)