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A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This is a Phase 2b, randomized, controlled, open-label clinical study evaluating the efficacy, safety, and local PK profiles of TNP-2092 administered via IA injection on a background of antibiotic treatment in participants with early postoperative (within 3 months after index arthroplasty) or acute hematogenous (within 4 weeks of infection) PJI after knee arthroplasty, without debridement, and in participants with chronic PJI (including PJI occurring after various joint arthroplasties and revision arthroplasties) requiring long-term antibiotic suppressive treatment.
Trial Details
NCT Number NCT07858916
Lead Sponsor TenNor Therapeutics (Zhongshan) Limited
Conditions
(from sponsor)		 Prosthetic Joint Infection (PJI)
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov