Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection (NCT06621251) | Clinical Trial Compass
Active ā Not RecruitingPhase 2
Study to Evaluate the Efficacy and Safety of TRL1068 for the Treatment of Prosthetic Joint Infection
United States60 participantsStarted 2025-04-08
Plain-language 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.
Who can participate
Age range18 Years ā 85 Years
SexALL
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Inclusion criteria
ā. Age 18 to 85 years, inclusive
ā. Chronic PJI:
ā. Systemic Host Grade of A or B \[McPherson 2011\] (Appendix 3) and either
ā. First chronic PJI of the hip or knee, confirmed by synovial fluid aspirate culture or
ā. Recurrent chronic PJI of the hip or knee confirmed by synovial fluid aspirate culture
ā. Willing to be randomized to either:
ā. 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
ā. Participate in an observational study arm that receives SoC (i.e., two-stage prosthetic joint replacement) and
Exclusion criteria
ā. PJI associated with presence of concomitant fungal infection or bacterial pathogens that, even when in planktonic form (i.e., when released from biofilm), cannot be adequately treated with available antibiotics.
What they're measuring
1
Efficacy of TRL1068 in eliminating the need for an SoC 2-stage exchange arthroplasty
ā. More than one draining sinus and single draining sinus of \> 1 cm
ā. Less than 3 years life expectancy based on underlying morbidities
ā. Expected to receive chronic suppressive antibiotic therapy
ā. Congestive heart failure; New York Heart Association (NYHA) Functional Classification of Heart Failure Grade \> 3B
ā. Uncontrolled diabetes, defined as hemoglobin A1c \> 7.4%.
ā. BMI \> 45
ā. Any acute illness within 14 days of Day 1 that could confound the evaluation of safety evaluation of TRL1068, especially local or systemic fungal and other known or suspected bacterial infections