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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with bone and joint infection caused by S. aureus managed in the reference center for BJI in Lyon, between 2001 and 2011.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of teicoplanin in S.aureus bone and joint infection	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.	90 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance of teicoplanin in S.aureus bone and joint infection	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.	6 weeks
Pharmacocinetiks characteristics : Cmin value	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.)	2 weeks

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2017
• Last Update Submitted That Met QC Criteria: June 2, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; Bone and joint infection; Teicoplanin; Subcutaneous administration
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Arthritis, Infectious; Staphylococcal Infections
• Other Study ID Numbers: 69HCL17_0385

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No