Prostheses InfectionPhase 4PROTEDINCT03746327
Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
A Phase 4 study testing Sivextro 200 milligrams Oral Tablet in people with Prostheses Infection, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
To evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one or two stages at 6 months of followup after stopping tedizolid treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostheses Infection
- What is being tested?
- Sivextro 200 milligrams Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 13 Feb 2020to 10 Mar 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female older than 18 years who accept and sign the informed consent.
- Infection signs onset more than 3 months after index arthroplasty.
- Diagnostic of chronic (≥3 weeks of clinical symptoms) hip or knee prosthetic joint infection according to MSIS criteria *(Parvizi J, Gherke T. Definition of peri-prosthetic joint infection. J Arthroplasty 2014; 29: 1331)
- Infection due to a tedizolid susceptible microorganism.
- Surgical approach: one or two - stage exchange of all implant components.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Patients with a prosthetic joint infection with negative cultures.
- Patients who undergo debridement without removing the prosthesis or only partially removed
- ≥15 days of other antibiotic treatment before starting tedizolid
- Life expeancy ≤ 1 year.
- Previous enrollment in this protocol.
- Hypersensitivity to tedizolid or any formulation excipients.
- Concurrent use of another investigational medication within 30 days of study entry.
- Women who are pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: English Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
To evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one or two stages at 6 months of followup after stopping tedizolid treatment.
Read the detailed description
To evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one or two stages at 6 months of followup after stopping tedizolid treatment.
Secondary objectives:
Evaluate the efficacy of tedizolid at 12 months of follow-up; evaluate the rate of gastrointestinal adverse events with tedizolid; determine the rate of haematological abnormalities during tedizolid treatment and; in case of two-stage exchange, the rate of positive cultures during reimplantation.
- Conditions
- Prostheses Infection
- Being tested
- Sivextro 200 milligrams Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sivextro 200 milligrams Oral TabletDrug
200 mg milligram per day during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sivextro arm | Experimental | 200 mg milligram per day during 4 weeks Receives: Drug: Sivextro 200 milligrams Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed incidence of local signs infection at 6 months after tedizolid
incidence or absence of local signs of infection at the 6 months after tedizolid treatment.
Measured: 6 months
Secondary outcomes (2)
Incidence of Adverse Events at 12 months after ending tedizolid treatment
incidence of adverse events at the 12 months after tedizolid treatment. number of Adverse Events as assessed
Measured: 12 months
Incidence of positive blood cultures during reimplantation on the two stage exchange cases.
incidence blood cultures at reimplantation,
Measured: 0, 7 days and months 1, 2, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start13 Feb 2020
- Primary completion31 Jan 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostheses InfectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746327
- Sponsor's protocol ID
- PROTEDI 2018-002465-18
- Acronym
- PROTEDI
- Status last verified
- Mar 2024
- First submitted
- 26 Jul 2018
- Last updated
- 12 Mar 2025
- 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- English Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
- ClinicalTrials.gov ID
- NCT03746327
- Acronym / sponsor ID
- PROTEDI / PROTEDI 2018-002465-18
- Conditions
- Prostheses Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 19 Nov 2018 (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.
To evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one or two stages at 6 months of followup after stopping tedizolid treatment.
Detailed description
To evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one or two stages at 6 months of followup after stopping tedizolid treatment.
Secondary objectives:
Evaluate the efficacy of tedizolid at 12 months of follow-up; evaluate the rate of gastrointestinal adverse events with tedizolid; determine the rate of haematological abnormalities during tedizolid treatment and; in case of two-stage exchange, the rate of positive cultures during reimplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sivextro arm | Experimental | Drug: Sivextro 200 milligrams Oral Tablet200 mg milligram per day during 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female older than 18 years who accept and sign the informed consent.
- Infection signs onset more than 3 months after index arthroplasty.
- Diagnostic of chronic (≥3 weeks of clinical symptoms) hip or knee prosthetic joint infection according to MSIS criteria *(Parvizi J, Gherke T. Definition of peri-prosthetic joint infection. J Arthroplasty 2014; 29: 1331)
- Infection due to a tedizolid susceptible microorganism.
- Surgical approach: one or two - stage exchange of all implant components.
Key exclusion criteria (8 listed)
- Patients with a prosthetic joint infection with negative cultures.
- Patients who undergo debridement without removing the prosthesis or only partially removed
- ≥15 days of other antibiotic treatment before starting tedizolid
- Life expeancy ≤ 1 year.
- Previous enrollment in this protocol.
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 |
|---|---|---|
| Sivextro 200 milligrams Oral Tablet200 mg milligram per day during 4 weeks | Drug | Sivextro arm |
Primary outcome
Investigator-assessed incidence of local signs infection at 6 months after tedizolid
Time frame: 6 months
incidence or absence of local signs of infection at the 6 months after tedizolid treatment.
2 secondary outcomes
Incidence of Adverse Events at 12 months after ending tedizolid treatment
Time frame: 12 months
Incidence of positive blood cultures during reimplantation on the two stage exchange cases.
Time frame: 0, 7 days and months 1, 2, 6, 12
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 12 Mar 2025.
- 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?
A Phase 4 study testing Sivextro 200 milligrams Oral Tablet in people with Prostheses Infection, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
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 8 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 12 Mar 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Investigator-assessed incidence of local signs infection at 6 months after tedizolid (time frame: 6 months). 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 12 Mar 2025.