Prostheses Infection
Conditions
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.
Interventions
DRUGSivextro 200 milligrams Oral Tablet
200 mg milligram per day during 4 weeks
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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, |
Countries
Spain
Outcome results
None listed