Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection
Trial Parameters
Brief Summary
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making pathogens substantially more susceptible to established antibiotic treatment regimens. This Phase 2 study is designed to assess efficacy and safety of TRL1068 in combination with a DAIR (debridement, antibiotics, and implant retention) procedure for chronic prosthetic joint infections of the knee and hip, specifically, eliminating the need for the standard of care 2-stage exchange surgery, so that the original prosthesis can be retained.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 85 years, inclusive 2. Chronic PJI: 1. Systemic Host Grade of A or B \[McPherson 2011\] (Appendix 3) and either 2. First chronic PJI of the hip or knee, confirmed by synovial fluid aspirate culture or 3. Recurrent chronic PJI of the hip or knee confirmed by synovial fluid aspirate culture 3. Willing to be randomized to either: 1. Receive TRL1068 and to be scheduled for DAIR between Day 15 + 7 days (i.e., between days 15-22) and 10 weeks of targeted antibiotic treatment or 2. Participate in an observational study arm that receives SoC (i.e., two-stage prosthetic joint replacement) and i. Sonication of the explanted prosthesis and performance of synovial fluid aspirates ii. Consents to conduct of stage 2 (implantation of new prosthesis) 4. At least 1 positive bacterial culture without concomitant fungal infection from the infected joint (a joint aspirate within 28 days prior to Screening is acceptable) 5. All identified pathogen(s) are susceptible to the