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

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.

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