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

Phase 2
Completed
Conditions
Osteoarticular Infection
Interventions
Registration Number
NCT01815541
Lead Sponsor
Centre Hospitalier Universitaire, Amiens
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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)
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
teicoplaninteicoplaninthis group receive the teicoplanin
Primary Outcome Measures
NameTimeMethod
measure of tolerance6 weeks

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

CHU Amiens

🇫🇷

Amiens, Picardie, France

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