Actively Recruiting
A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in Participants With Early or Acute Hematogenous PJI Requiring or Not Requiring DAIR After TKA, or Requiring Long-term Antibiotic Therapy
Led by TenNor Therapeutics Inc. · Updated on 2026-03-05
33
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
TenNor Therapeutics Inc.
Lead Sponsor
F
First Affiliated Hospital of Xinjiang Medical University
Collaborating Sponsor
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 1/2, 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 treatment's 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
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 7 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 14 days for intra-articular injections; 8 weeks for oral antibiotics
Participants receive intra-articular injections of study drugs and oral antibiotics as prescribed for infection treatment.
Daily visits for up to 14 days for injections and regular visits during the 8-week oral antibiotic period
Duration - Up to 6 months after starting treatment
Participants are monitored for safety, treatment response, and any adverse events after treatment completion.
Periodic visits for up to 6 months
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Actively Recruiting
Research Team
L
Li Cao
J
Jing Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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