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Recruiting NCT07858916

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

Conditions: Prosthetic Joint Infection (PJI)

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 40
Sponsor: TenNor Therapeutics (Zhongshan) Limited

Location: The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang

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.

Eligibility Criteria

Inclusion Criteria: 1. Participants with PJI that is early postoperatively (within 3 months of index arthroplasty) or acute hematogenous (within 4 weeks of infectious symptoms) after knee arthroplasty; or participants with chronic PJI requiring long-term antibiotic suppressive therapy (including PJI occurring after any type of joint arthroplasty or revision arthroplasty). 2. PJI that, in the investigator's judgment, is suspected or confirmed to be caused by Gram-positive bacteria. 3. Agrees to receive local IA injection of TNP-2092. 4. Age ≥18 years and ≤80 years at the time of signing the informed consent form (ICF), regardless of sex. 5. The implanted joint prosthesis is well fixed. 6. No sinus tract in the affected joint. 7. Body mass index (BMI) ≥18 kg/m² and ≤40 kg/m². 8. Female participants who are of childbearing potential and those who are \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07858916). StuddyBuddy aggregates publicly available trial information.