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

NCT03177369 | Completed

• 1 other identifier: 69HCL17_0385
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Bone and joint infection; Staphylococcus aureus; Teicoplanin; Subcutaneous administration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tolerance of teicoplanin in S.aureus bone and joint infection

  6 weeks

• Pharmacocinetiks characteristics : Cmin value

  2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 6, 2017

Record last verified: 2017-06

Locations

FR (1)