Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT03746327
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Organization:
Study Overview
Official Title:
English Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTEDI
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: