Bone and Joint InfectionTediSATNCT04662736
Tedizolid Suppressive Antimicrobial Therapy in a Reference Center
An observational study of Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
the aim of the study is to describe the management and outcome of patients having an osteo-articular infection treated by tedizolid as a suppressive antibiotic therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone and Joint Infection
- What is being tested?
- patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 1 Apr 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: patients having an osteo-articular infection treated with tedizolid as a suppressive antibiotic therapy managed at the CRIOAc LYON, Croix-Rousse Hospital
Who may be able to join
- patients having an osteo-articular infection treated with tedizolid as a suppressive antibiotic therapy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tedizolid Suppressive Antimicrobial Therapy
the aim of the study is to describe the management and outcome of patients having an osteo-articular infection treated by tedizolid as a suppressive antibiotic therapy.
- Conditions
- Bone and Joint Infection
- Being tested
- patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy
- Keywords
- bone and joint infection, tedizolid, suppressive antibiotic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapyOther
description of osteo-articular infection managed with tedizolid as a suppressive antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy | Not described Receives: Other: patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy
proportion of patients having tedizolid as a suppressive antibiotic therapy
Measured: between 2016 and 2021
rate of failure in patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic
proportion of patients having a failure under tedizolid as a suppressive antibiotic therapy
Measured: 2 years
rate of adverse event in patients having had a BJI/PJI treated with tedizolid as a suppressive
proportion of patients having a adverse event under tedizolid as a suppressive antibiotic therapy
Measured: through study completion, an average of 1 year
Description of patients having had a BJI/PJI treated with tedizolid as a suppressive
type of patients: age, CMI, comorbidities...
Measured: 2 years
Description of BJI/PJI treated with tedizolid as a suppressive
implant or prothese or not, acute/ chronic, bacteriology
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Feb 2021
- Primary completion1 Feb 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662736
- Sponsor's protocol ID
- 232
- Acronym
- TediSAT
- Status last verified
- Jun 2021
- First submitted
- 25 Nov 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tedizolid Suppressive Antimicrobial Therapy
- ClinicalTrials.gov ID
- NCT04662736
- Acronym / sponsor ID
- TediSAT / 232
- Conditions
- Bone and Joint Infection
- Keywords
- bone and joint infection, tedizolid, suppressive antibiotic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 10 Dec 2020 (actual)
- 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.
the aim of the study is to describe the management and outcome of patients having an osteo-articular infection treated by tedizolid as a suppressive antibiotic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy | – | Other: patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients having an osteo-articular infection treated with tedizolid as a suppressive antibiotic therapy managed at the CRIOAc LYON, Croix-Rousse Hospital
Key inclusion criteria (1 listed)
- patients having an osteo-articular infection treated with tedizolid as a suppressive antibiotic therapy
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapydescription of osteo-articular infection managed with tedizolid as a suppressive antibiotic therapy | Other | patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy |
Primary outcome
rate of patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy
Time frame: between 2016 and 2021
proportion of patients having tedizolid as a suppressive antibiotic therapy
rate of failure in patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic
Time frame: 2 years
proportion of patients having a failure under tedizolid as a suppressive antibiotic therapy
rate of adverse event in patients having had a BJI/PJI treated with tedizolid as a suppressive
Time frame: through study completion, an average of 1 year
proportion of patients having a adverse event under tedizolid as a suppressive antibiotic therapy
Description of patients having had a BJI/PJI treated with tedizolid as a suppressive
Time frame: 2 years
type of patients: age, CMI, comorbidities...
Description of BJI/PJI treated with tedizolid as a suppressive
Time frame: 2 years
implant or prothese or not, acute/ chronic, bacteriology
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 21 Jun 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone and Joint Infection, run by Hospices Civils de Lyon 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 1 inclusion and 1 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 21 Jun 2021. 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.
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?
rate of patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy (time frame: between 2016 and 2021). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2021; AzTrials last refreshed its copy on 2 Nov 2026.