Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study
TEICOPLANIN
2 other identifiers
interventional
30
1 country
1
Brief Summary
This is a biomedical research, prospective, mono centric, tolerance study Of the administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 15, 2013
CompletedFirst Posted
Study publicly available on registry
March 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedSeptember 19, 2025
September 1, 2025
2.3 years
March 15, 2013
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
teicoplanin
EXPERIMENTALthis group receive the teicoplanin
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, Picardie, 80054, France
Related Publications (1)
El Samad Y, Lanoix JP, Bennis Y, Diouf M, Saroufim C, Brunschweiler B, Rousseau F, Joseph C, Hamdad F, Ait Amer Meziane M, Routier S, Schmit JL. Tolerability and Plasma Drug Level Monitoring of Prolonged Subcutaneous Teicoplanin Treatment for Bone and Joint Infections. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6365-8. doi: 10.1128/AAC.00351-16. Print 2016 Oct.
PMID: 27458228RESULT
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youssef El SAMAD, PH
CHU Amiens, France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2013
First Posted
March 21, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2015
Study Completion
July 1, 2015
Last Updated
September 19, 2025
Record last verified: 2025-09