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

August 1, 2016 updated by: Centre Hospitalier Universitaire, Amiens
This is a biomedical research, prospective, mono centric, tolerance study Of the administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: teicoplanin
this group receive the teicoplanin
Drug: teicoplanin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Youssef El SAMAD, PH, CHU Amiens, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 15, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2012_843_0008
  • 2012-003690-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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