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Clinical Trials/NCT01815541
NCT01815541
Completed
Phase 2

Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study

Centre Hospitalier Universitaire, Amiens1 site in 1 country30 target enrollmentMarch 1, 2013

Overview

Phase
Phase 2
Intervention
teicoplanin
Conditions
Osteoarticular Infection
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
30
Locations
1
Primary Endpoint
measure of tolerance
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

This is a biomedical research, prospective, mono centric, tolerance study Of the administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.

Registry
clinicaltrials.gov
Start Date
March 1, 2013
End Date
July 1, 2015
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient over 18 years
  • Inpatient orthopedic surgery
  • Achieved a bone and joint infection documented gram + (staphylococci golden coagulase-negative staphylococci, enterococci, streptococci)
  • Bacteria resistant to lincosamides, quinolones and rifampicin
  • Bacteria susceptible to teicoplanin (MIC ≤ 4 mg / L)
  • Balanced patient teicoplanin administered intravenously (2 successive doses between 30 and 40 mg / mL)

Exclusion Criteria

  • Patient not affiliated to the social security
  • Pregnant and lactating women
  • Known hypersensitivity to teicoplanin (rash, ...)
  • Patients with a central catheter or an implantable chamber
  • Patient hemodialysis
  • Patient has another participant biomedical research on a drug to prevent drug interactions
  • Patient minor
  • Patient major protected (protection of the court, wardship, trusteeship)
  • Patient admitted for emergency or incapable of consent

Arms & Interventions

teicoplanin

this group receive the teicoplanin

Intervention: teicoplanin

Outcomes

Primary Outcomes

measure of tolerance

Time Frame: 6 weeks

The frequencies of adverse reactions at the injection site SC will be measured to assess the local tolerance of teicoplanin by SC.

Study Sites (1)

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