Efficacy and tolerance of 4 weeks of tedizolid in prosthetic joint infections treated with implant removal

Phase 1

• Conditions: prosthetic joint infections treated with implant removal.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-002465-18-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-09
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 follow-up after stopping tedizolid treatment.;<br> Secondary Objective: - Evaluate the efficacy of tedizolid at 12 months of follow-up<br> - evaluate the rate of gastrointestinal adverse events with tedizolid<br> - determine the rate of haematological abnormalities during tedizolid treatment<br> - in case of two-stage exchange, the rate of positive cultures during reimplantation.<br> ;Primary end point(s): The primary endpoint will be the investigator-assessed clinical outcome (surgical wound closed and absence of local signs of infection) at the 9th visit (6 months after finishing tedizolid treatment).;Timepoint(s) of evaluation of this end point: The 9th visit (6 months after finishing tedizolid treatment).