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

Phase 4

Completed

• Conditions: Prostheses Infection
• Interventions: Drug: Sivextro 200 milligrams Oral Tablet

• Registration Number: NCT03746327
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Study Start: 2020-02-13
• Primary Completion: 2024-01-31
• Status Verified: 2024-03
• Study Completion: 2024-03-10
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sivextro arm	Sivextro 200 milligrams Oral Tablet	200 mg milligram per day during 4 weeks

Primary Outcome Measures

Name	Time	Method
Investigator-assessed incidence of local signs infection at 6 months after tedizolid	6 months	incidence or absence of local signs of infection at the 6 months after tedizolid treatment.

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events at 12 months after ending tedizolid treatment	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.	0, 7 days and months 1, 2, 6, 12	incidence blood cultures at reimplantation,

Trial Locations

Locations (1)

Laura Morata; 🇪🇸 Barcelona, Spain