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

Prostheses Infection Clinical Trial

— PROTEDI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03746327
• Other study ID #: PROTEDI 2018-002465-18
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2020
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 28, 2022
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Prostheses Infection

Intervention

Drug:
• Sivextro 200 milligrams Oral Tablet
200 mg milligram per day during 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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