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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

Tracking Information
First Submitted Date  ICMJE July 26, 2018
First Posted Date  ICMJE November 19, 2018
Last Update Posted Date February 19, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03746327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • 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
  • 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,
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
Official Title  ICMJE English Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostheses Infection
Intervention  ICMJE Drug: Sivextro 200 milligrams Oral Tablet
200 mg milligram per day during 4 weeks
Study Arms  ICMJE Experimental: Sivextro arm
200 mg milligram per day during 4 weeks
Intervention: Drug: Sivextro 200 milligrams Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03746327
Other Study ID Numbers  ICMJE PROTEDI 2018-002465-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
Study Sponsor  ICMJE Fundacion Clinic per a la Recerca Biomédica
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundacion Clinic per a la Recerca Biomédica
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP