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

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ClinicalTrials.gov Identifier: NCT03746327
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

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.

Condition or disease Intervention/treatment Phase
Prostheses Infection Drug: Sivextro 200 milligrams Oral Tablet Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: English Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sivextro arm
200 mg milligram per day during 4 weeks
Drug: Sivextro 200 milligrams Oral Tablet
200 mg milligram per day during 4 weeks




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of Adverse Events at 12 months after ending tedizolid treatment [ Time Frame: 12 months ]
    incidence of adverse events at the 12 months after tedizolid treatment. number of Adverse Events as assessed

  2. Incidence of positive blood cultures during reimplantation on the two stage exchange cases. [ Time Frame: 0, 7 days and months 1, 2, 6, 12 ]
    incidence blood cultures at reimplantation,



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Anna Cruceta, Project manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT03746327     History of Changes
Other Study ID Numbers: PROTEDI 2018-002465-18
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Tedizolid
Tedizolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents