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

NCT ID: NCT01815541

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarticular Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

teicoplanin

this group receive the teicoplanin

Group Type EXPERIMENTAL

teicoplanin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

teicoplanin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Youssef El SAMAD, PH

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Amiens

Amiens, Picardie, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 27458228 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012-003690-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PI2012_843_0008

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.