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

Primary Purpose

Osteoarticular Infection

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

teicoplanin

About this trial

This is an interventional treatment trial for Osteoarticular Infection focused on measuring subcutaneous teicoplanin, osteoarticular, infections, tolerance, teicoplanin

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU Amiens

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

teicoplanin

Arm Description

this group receive the teicoplanin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01815541

First Posted

March 15, 2013

Last Updated

August 1, 2016

Sponsor

Centre Hospitalier Universitaire, Amiens

1. Study Identification

Unique Protocol Identification Number

NCT01815541

Brief Title

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

Acronym

TEICOPLANIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarticular Infection

Keywords

subcutaneous teicoplanin, osteoarticular, infections, tolerance, teicoplanin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

teicoplanin

Arm Type

Experimental

Arm Description

this group receive the teicoplanin

Intervention Type

Drug

Intervention Name(s)

teicoplanin

Primary Outcome Measure Information:

Title

measure of tolerance

Description

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Youssef El SAMAD, PH

Organizational Affiliation

CHU Amiens, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Amiens

City

Amiens

State/Province

Picardie

ZIP/Postal Code

80054

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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