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

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Completed; Phase 4

Conditions: Prostheses Infection

Treatments: Drug: Sivextro 200 milligrams Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03746327

PROTEDI 2018-002465-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Sivextro arm

Experimental group

Description:

200 mg milligram per day during 4 weeks

Treatment:

Drug: Sivextro 200 milligrams Oral Tablet