Prosthetic Joint Infection (PJI)

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.

Prosthetic joint infection (PJI) is a significant cause of failure in hip and knee arthroplasty and is often difficult to diagnose using current methods. This study aims to identify novel biomarkers for early and accurate diagnosis of PJI using nanopore sequencing technology (Oxford Nanopore Technologies). By analysing microbial profiles and host immune responses in samples from patients undergoing revision surgery, the study will compare infected and non-infected cases. Biomarkers will be investigated in periprosthetic tissue as well as less invasive sample types, including synovial fluid and blood, with the goal of improving early diagnosis and guiding future treatment strategies.