Status:
WITHDRAWN
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
Lead Sponsor:
Adaptive Phage Therapeutics, Inc.
Conditions:
Prosthetic Joint Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
Detailed Description
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by at least 1 of the following organisms: Staphylococcus aureu...
Eligibility Criteria
Inclusion
- Males or females ≥18 years of age
- Recurrent PJI of the knee or hip
- Female patients of childbearing potential who agree to use contraception.
- Confirmed phage match
- No anticipated need for long-term antibiotics
Exclusion
- Soft tissue defect requiring reconstruction
- Hardware misalignment
- Additional orthopedic hardware in connection with the infected prosthesis
- Active infection (other than PJI) requiring long term IV antibiotics
- Unable to tolerate SAT
- Septic shock or hemodynamic instability
- Stage 4 or greater chronic kidney disease
- Liver disease
- Decompensated heart failure
- Positive drug screen
- Receiving chemotherapy
- Immunocompromised
- Treatment with antiviral medication within 2 weeks prior to randomization
- Currently participating in another clinical trial
- Known phage allergy
- Pregnant/ breast feeding
- Lack of capacity to consent
Key Trial Info
Start Date :
March 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05269134
Start Date
March 27 2023
End Date
July 1 2027
Last Update
November 30 2023
Active Locations (10)
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1
University of California San Diego Medical Center
San Diego, California, United States, 92037
2
Hartford Health Care Bone & Joint Insitute
Hartford, Connecticut, United States, 06106
3
Snake River Research
Idaho Falls, Idaho, United States, 83404
4
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201