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

• Status: Not yet recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Treatments: Tedizolid phosphate; Torezolid; Torezolid phosphate

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