TRL1068 for Prosthetic Joint Infection
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on chronic suppressive antibiotic therapy and should not have received another investigational drug recently. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the treatment TRL1068 for Prosthetic Joint Infection?
The research shows that a similar treatment approach, involving surgical cleaning and antibiotics, successfully eradicated infections in patients with prosthetic joint infections, allowing them to keep their joint implants. This suggests that TRL1068, when used with similar methods, might also be effective in treating these infections.12345
What is the purpose of this trial?
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
This trial is for adults aged 18-85 with a first or recurrent chronic prosthetic joint infection in the knee or hip, confirmed by culture. Participants must have stable implants without osteomyelitis and be able to consent and comply with study procedures, including follow-up visits.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
TRL1068 is administered at 15 mg/kg IV on Day 1 and subsequently at 7.5 mg/kg on Days 15, 29, and 43. A DAIR procedure is completed between Day 15-22.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and efficacy measures.
Treatment Details
Interventions
- DAIR
- TRL1068
Find a Clinic Near You
Who Is Running the Clinical Trial?
Trellis Bioscience LLC
Lead Sponsor