Osteoarticular InfectionPhase 2TEICOPLANINNCT01815541
Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study
A Phase 2 study testing teicoplanin in people with Osteoarticular Infection, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
This is a biomedical research, prospective, mono centric, tolerance study Of the administration of subcutaneous teicoplanin in the treatment of osteoarticular infections. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteoarticular Infection
- What is being tested?
- teicoplanin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- Patient minor
- Patient major protected (protection of the court, wardship, trusteeship)
- Patient admitted for emergency or incapable of consent
Trial locations and contacts
1 site in 1 country.
About this study
This is a biomedical research, prospective, mono centric, tolerance study Of the administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.
- Conditions
- Osteoarticular Infection
- Being tested
- teicoplanin
- Keywords
- subcutaneous teicoplanin, osteoarticular, infections, tolerance, teicoplanin
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teicoplaninDrug
| Study group | Role | What they receive |
|---|---|---|
| teicoplanin | Experimental | this group receive the teicoplanin Receives: Drug: teicoplanin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarticular InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youssef El SAMAD, PH, Principal investigator, CHU Amiens, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815541
- Sponsor's protocol ID
- PI2012_843_0008
- Other IDs
- 2012-003690-25
- Acronym
- TEICOPLANIN
- Status last verified
- Sep 2025
- First submitted
- 15 Mar 2013
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27458228
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study
- ClinicalTrials.gov ID
- NCT01815541
- Acronym / sponsor ID
- TEICOPLANIN / PI2012_843_0008
- Conditions
- Osteoarticular Infection
- Keywords
- subcutaneous teicoplanin, osteoarticular, infections, tolerance, teicoplanin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a biomedical research, prospective, mono centric, tolerance study Of the administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| teicoplanin | Experimental | Drug: teicoplaninthis group receive the teicoplanin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| teicoplanin | Drug | teicoplanin |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 27458228El 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youssef El SAMAD, PH principal investigator
CHU Amiens, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing teicoplanin in people with Osteoarticular Infection, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of tolerance (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01815541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.