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TNP-2092 in Periprosthetic Joint Infection
NCT06889701Phase 2
Key facts
- Status
- Recruiting
- Start
- Apr 2025
- Primary completion
- Jan 2027
- Countries
- 1
- Sponsor
- TenNor Therapeutics
- Drugs
- rifaquizinone
- Conditions
- periprosthetic joint infection (PJI)
01
Overview
Phase 2, randomised, open-label trial of rifaquizinone in periprosthetic joint infection (PJI) (4 arms), sponsored by TenNor Therapeutics. Primary endpoint: Adverse Events. Started Apr 2025; status: recruiting.
02
Design
4 arms- Study design
- RandomizedOpen-label
Sentinel group
TNP-2092 50 mg IA + vancomycin IV + oral antibiotics
Experimental group
TNP-2092 50 mg IA + vancomycin IV + oral antibiotics
Control group
vancomycin IA + vancomycin IV + oral antibiotics
Expansion group
TNP-2092 50 mg IA based on the background treatment
03
Who it enrols
Adults with early or acute hematogenous periprosthetic joint infection caused by Gram-positive bacteria, requiring or not requiring DAIR therapy after TKA, or requiring long-term antibiotic suppression therapy.
04
Endpoints
Primary
Adverse Events
Secondary
TNP-2092 concentrations in synovial fluid
Maximum Observed Plasma Concentration
Time to Reach the Maximum Observed Plasma Concentration
Area under the curve from the time of dosing to the last measurable concentration
Area under the curve from the time of dosing to infinity
Elimination half-life
Maximum observed concentration at steady state
Time to maximum concentration at steady state
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