Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal (PROTEDI)
Primary Purpose
Prostheses Infection
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sivextro 200 milligrams Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Prostheses Infection
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sivextro arm
Arm Description
200 mg milligram per day during 4 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Incidence of positive blood cultures during reimplantation on the two stage exchange cases.
incidence blood cultures at reimplantation,
Full Information
NCT ID
NCT03746327
First Posted
July 26, 2018
Last Updated
February 4, 2020
Sponsor
Fundacion Clinic per a la Recerca Biomédica
1. Study Identification
Unique Protocol Identification Number
NCT03746327
Brief Title
Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
Acronym
PROTEDI
Official Title
English Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostheses Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sivextro arm
Arm Type
Experimental
Arm Description
200 mg milligram per day during 4 weeks
Intervention Type
Drug
Intervention Name(s)
Sivextro 200 milligrams Oral Tablet
Intervention Description
200 mg milligram per day during 4 weeks
Primary Outcome Measure Information:
Title
Investigator-assessed incidence of local signs infection at 6 months after tedizolid
Description
incidence or absence of local signs of infection at the 6 months after tedizolid treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events at 12 months after ending tedizolid treatment
Description
incidence of adverse events at the 12 months after tedizolid treatment. number of Adverse Events as assessed
Time Frame
12 months
Title
Incidence of positive blood cultures during reimplantation on the two stage exchange cases.
Description
incidence blood cultures at reimplantation,
Time Frame
0, 7 days and months 1, 2, 6, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
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