NCT01815541
Completed
Phase 2
Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study
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.
Investigators
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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