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OpenTrials
Completed

NCT Number: NCT03177369

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Efficacy of teicoplanin in S.aureus bone and joint infection

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Pharmacocinetiks characteristics : Cmin value

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2017
Registry last updated
Jun 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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