Status:
WITHDRAWN
Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
Lead Sponsor:
Adaptive Phage Therapeutics, Inc.
Conditions:
Prosthetic Joint Infection
Bacterial Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint inf...
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 1 or 2 of the following organisms: Staphylococcus aureus, S...
Eligibility Criteria
Inclusion
- Males or females ≥18 years of age.
- Stopped or not received SAT for 2 weeks
- Female patients of childbearing potential who agree to use contraception.
- First time chronic prosthetic joint infection
- 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
- Unable to tolerate SAT
- Septic shock or hemodynamic instability.
- Chronic kidney disease
- Liver disease
- Decompensated heart failure.
- Positive drug screen
- Receiving chemotherapy
- Immunocompromised
- Antiviral treatment within 2 weeks prior to DAIR
- Currently participating in another clinical trial
- Known phage allergy
- Pregnant/ breastfeeding
- Lack of capacity to consent
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05269121
Start Date
September 1 2022
End Date
November 1 2024
Last Update
February 22 2024
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