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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
Fundacion Clinic per a la Recerca Biomédica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostheses Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female older than 18 years who accept and sign the informed consent.
  2. Infection signs onset more than 3 months after index arthroplasty.
  3. 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)
  4. Infection due to a tedizolid susceptible microorganism.
  5. Surgical approach: one or two - stage exchange of all implant components.
  6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Patients with a prosthetic joint infection with negative cultures.
  2. Patients who undergo debridement without removing the prosthesis or only partially removed
  3. ≥15 days of other antibiotic treatment before starting tedizolid
  4. Life expeancy ≤ 1 year.
  5. Previous enrollment in this protocol.
  6. Hypersensitivity to tedizolid or any formulation excipients.
  7. Concurrent use of another investigational medication within 30 days of study entry.
  8. 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

    First Posted
    July 26, 2018
    Last Updated
    February 4, 2020
    Sponsor
    Fundacion Clinic per a la Recerca Biomédica
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    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

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    Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal

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