A Phase 1, Blinded, Single Ascending Dose Study to Evaluate Safety, Pharmacokinetics, and Activity of TRL1068 in Subjects with Prosthetic Joint Infection of the Knee or Hip, Undergoing Primary Two Stage Exchange Arthroplasty
Who is this study for? Patients with prosthetic joint infection of the knee or hip undergoing primary two stage exchange arthroplasty
What treatments are being studied? TRL1068
Status: Completed
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens. This initial study is designed to assess overall safety and pharmacokinetics (PK) of TRL1068. The overall goal of the development program is to demonstrate that TRL1068 can facilitate effectiveness of a single stage joint replacement or preservation of the original infected prosthetic joint in a substantial proportion of patients with PJI.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Diagnosis of PJI of the knee or hip
• Identified pathogen(s) must be susceptible to antibiotic regimen
• Planned/scheduled for primary two-stage exchange arthroplasty
• BMI \< 40 kg/m²
• Willing and able to provide written informed consent
• Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
• Men and women of child bearing potential (WOCBP) must be willing to practice a highly effective method of contraception
Collaborators: Gulfcoast Research Institute, University of Southern California, Wellcome Trust, University of Florida, Biomedical Advanced Research and Development Authority, University of Virginia, University of Alabama at Birmingham, Sinai Hospital of Baltimore, The Methodist Hospital Research Institute, University of California, Los Angeles, Phoenix Clinical Research