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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostheses Infection

Intervention / Treatment
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* Drug: Sivextro 200 milligrams Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sivextro arm<br>200 mg milligram per day during 4 weeks | Drug: Sivextro 200 milligrams Oral Tablet<br>* 200 mg milligram per day during 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator-assessed incidence of local signs infection at 6 months after tedizolid | incidence or absence of local signs of infection at the 6 months after tedizolid treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events at 12 months after ending tedizolid treatment | incidence of adverse events at the 12 months after tedizolid treatment. number of Adverse Events as assessed | 12 months | 
| Incidence of positive blood cultures during reimplantation on the two stage exchange cases. | incidence blood cultures at reimplantation, | 0, 7 days and months 1, 2, 6, 12 |