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

Completed

• Conditions: Teicoplanin-based Antimicrobial Therapy; Bone and Joint Infection; Staphylococcus Aureus

• Registration Number: NCT03177369
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-06
• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-02
• Last Update Submitted: 2017-06-02
• Study First Posted: 2017-06-06
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with bone and joint infection caused by S. aureus receiving teicoplanin (IV or SC) as part to treat the infection

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Exclusion Criteria

• Patients with diabetic foot- and decubitus ulcer-related BJI

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.)
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.

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon; 🇫🇷 Lyon, France