drugset
drugset / Trial / NCT07858916

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

NCT07858916 ↗

Phase 2 Not yet recruiting 40 enrolled TenNor Therapeutics Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2026-10
Primary completion
2027-09
Completion
2028-03

Drugs

EvaluationDrugModalityDoseRoute
Subject RIFAQUIZINONE Small molecule 50 mg Intravitreal
Background Levofloxacin Small molecule 0.5 g Oral
Background Minocycline Small molecule 100 mg Oral
Background Vancomycin Other / unclassified 0.5 g Intravenous
Background Vancomycin Other / unclassified 1 g Intravenous

Indications

periprosthetic joint infection