What is TNP-2092 studying for periprosthetic joint infection (PJI)?

TNP-2092 is being studied to evaluate its safety, how the body processes it, and its effects when given directly into the joint alongside standard antibiotic treatments for PJI. The study focuses on early or acute infections after joint replacement surgeries and is sponsored by TenNor Therapeutics Inc. Participants will help researchers understand if this treatment approach is tolerable and how it behaves in the body.

Who may be eligible for this periprosthetic joint infection (PJI) clinical trial?

Adults aged 18 years or older with early or acute hematogenous PJI caused by Gram-positive bacteria may be eligible. Eligible participants must have a well-fixed prosthetic joint, no sinus tract to the prosthesis, and a body mass index between 18 and 34 kg/m². Participants also need to agree to hospitalization for 2 weeks for treatment. Please review eligibility criteria for more details.

Is there any cost to participate in this periprosthetic joint infection (PJI) clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses vary and may not be covered. Participants should plan for their own travel and accommodation costs if applicable.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06889701

Phase 12 Study of TNP-2092 Injection for Safety and Effectiveness in Adults with Early or Acute Periprosthetic Joint Infection After Knee Replacement or Long-Term Antibiotic Treatment

Led by TenNor Therapeutics Inc. · Updated on 2026-03-05

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying participants with early or acute hematogenous periprosthetic joint infection PJI following total knee arthroplasty TKA or other joint replacement surgeries. The study aims to evaluate the safety, tolerability, and pharmacokinetics PK of TNP-2092 given by intra-articular IA injection alongside vancomycin intravenous IV and oral antibiotics. This Phase 12, randomized, controlled, open-label study explores treatment options for PJI patients requiring or not requiring debridement, antibiotics, and implant retention DAIR therapy or long-term antibiotic suppression. Participants are assigned to one of four groups a sentinel group receiving TNP-2092 IA plus vancomycin IV and oral antibiotics, an experimental group receiving the same, a control group receiving vancomycin IA plus vancomycin IV and oral antibiotics, or an expansion group receiving TNP-2092 IA based on background treatment. TNP-2092 is administered at 50 mg via IA injection once daily for 14 days, with dose adjustments allowed based on drug concentrations and safety. Oral antibiotic treatment lasts 8 weeks, and vancomycin IV and IA are given daily for 14 days. Participants undergo screening assessments within 7 days before starting the study and must agree to hospitalization for 2 weeks of IA injections. Researchers will monitor safety by tracking adverse events through Day 187 and measure TNP-2092 concentrations in synovial fluid and plasma at multiple time points. They will also assess treatment responses at Day 14 and study end, along with treatment failure within 6 months. The study involves regular blood tests and clinical evaluations to evaluate the treatments pharmacokinetics and local and systemic effects.

CONDITIONS

Brief Title

A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requiring or not requiring DAIR therapy after TKA, or requiring long-term antibiotic suppression therapy for PJI including after joint replacements and revision surgeries.
Suspected or confirmed Gram-positive bacterial infection causing PJI, including resistant Staphylococcus strains.
Agree to be hospitalized for 2 weeks for intra-articular injections.
Age 18 years or older at informed consent.
Implanted prosthetic joint must be well fixed.
No sinus tract communicating with the prosthesis.
Body mass index (BMI) between 18 and 34 kg/m².
Agree to use effective contraception from consent through 8 weeks after last dose; males must refrain from sperm donation during this period.

You will not qualify if you...

History of hypersensitivity or intolerance to vancomycin or TNP-2092.
Definite PJI caused by Gram-negative, fungal, Enterococcus, Mycobacterium, or mixed infections.
Definite systemic infection (sepsis).
Expected survival less than 1 year.
Female participants who are pregnant, lactating, or have positive pregnancy tests.
Medical or surgical conditions affecting study participation or treatment interpretation, including active malignancy, metabolic disease, substance abuse, or significant lab abnormalities.
Serious liver, blood, or immune disorders including recent hepatitis, elevated liver enzymes, end-stage liver disease, neutropenia, recent chemotherapy, radiation, or immunosuppressants.
Positive AIDS antibody screening.
Severe renal disease or creatinine clearance below 30 mL/min.
Use of investigational agents within 30 days or 5 half-lives before first study dose.
Inability to comply with protocol or study drug administration as judged by investigator.

Research Team

Li Cao

Jing Chen

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