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

Brief 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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

status

RECRUITING

phase

PHASE2

study type

INTERVENTIONAL

enrollment

40

sponsor

TenNor Therapeutics (Zhongshan) Limited

conditions

Prosthetic Joint Infection (PJI)

interventions

DRUG: TNP-2092 for injection; DRUG: Vancomycin Hydrochloride for Injection; DRUG: Oral antibiotics; DRUG: Appropriate intravenous and/or oral antibiotics

start date

2026-10-21

start date type

ACTUAL

primary completion date

2027-09-01

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters