Status:
COMPLETED
Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections
Lead Sponsor:
Trellis Bioscience LLC
Collaborating Sponsors:
University of California, Los Angeles
Biomedical Advanced Research and Development Authority
Conditions:
Prosthetic Joint Infection
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief 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 tr...
Detailed Description
Approximately 75% of all clinically significant human infections are estimated to be biofilm-related. Prosthetic joint infections are a classical example of difficult to eradicate infections associate...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Evidence of active infection other than bacterial PJI of the knee or hip
- Inability to receive or intolerant to pathogen-appropriate systemic or oral antibiotic therapy
- Chronic obstructive pulmonary disease (COPD)
- Child-Pugh score \> 6
- Congestive heart failure
- Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids
- Active malignancy, or history of malignancy or chemotherapy within the past 2 years
- Active or history of autoimmune disease
- Uncontrolled diabetes, defined as hemoglobin A1c \> 7.4%
- Clinically significant abnormality on electrocardiogram (ECG) that would preclude subject from undergoing two-stage exchange arthroplasty
- Clinically significant serum chemistry or hematology abnormalities
- Any acute illness within 14 days of Day 1 that could confound the evaluation of safety evaluation
- Known or suspected intolerance or hypersensitivity to any biologic medication
- Received a therapeutic antibody or biologic within the 6 months prior to Screening
- Positive serum test for pregnancy, pregnant, or nursing women
- Positive reverse transcription polymerase chain reaction (RT -PCR) or alternative (antigen) test for acute respiratory syndrome coronavirus 2
- History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the subject's ability to comply with the study requirements
- Any other comorbidity or condition that, in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with the study requirements
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04763759
Start Date
February 8 2021
End Date
March 13 2024
Last Update
November 21 2024
Active Locations (9)
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1
University of Alabama
Birmingham, Alabama, United States, 35205
2
USC
Los Angeles, California, United States, 90033
3
UCLA
Santa Monica, California, United States, 90404
4
University of Florida
Gainesville, Florida, United States, 32611