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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sivextro arm | Experimental | 200 mg milligram per day during 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sivextro 200 milligrams Oral Tablet | Drug | 200 mg milligram per day during 4 weeks |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laura Morata | Barcelona | Spain |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 14, 2025 | |
| Reset | Nov 24, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 14, 2025 | Nov 24, 2025 |
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incidence blood cultures at reimplantation, |
| 0, 7 days and months 1, 2, 6, 12 |