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

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 2

Conditions: Osteoarticular Infection

Treatments: Drug: teicoplanin

Study type: Interventional

Funder types: Other

Identifiers

NCT01815541

PI2012_843_0008

2012-003690-25 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

teicoplanin

Experimental group

Description:

this group receive the teicoplanin

Treatment:

Drug: teicoplanin