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

Osteoarticular Infection Clinical Trial

— TEICOPLANIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815541
• Other study ID #: PI2012_843_0008
• Secondary ID: 2012-003690-25
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2013
• Last updated: August 1, 2016
• Start date: March 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Osteoarticular Infection

Intervention

Drug:
• teicoplanin

Locations

Country	Name	City	State
France	CHU Amiens	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of tolerance	The frequencies of adverse reactions at the injection site SC will be measured to assess the local tolerance of teicoplanin by SC.	6 weeks	No