Status:
WITHDRAWN
Bacteriophage Therapy in Patients With Prosthetic Joint Infections
Lead Sponsor:
Adaptive Phage Therapeutics, Inc.
Collaborating Sponsors:
Mayo Clinic
Conditions:
Prosthetic Joint Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 1 or 2 of the following organisms: Staphylococcus aureus, S...
Eligibility Criteria
Inclusion
- General
- Males or females ≥18 years of age.
- Female patients of childbearing potential who agree to use contraception.
- Candidate for a two-stage exchange arthroplasty.
- Chronic prosthetic joint infection
- General
Exclusion
- Prior history of prosthetic joint infections (PJI) of same joint treated surgically other than one prior Debridement Antibiotics and Implant Retention procedure
- Soft tissue defect requiring reconstruction
- Hardware misalignment or loosening
- Active osteomyelitis
- Septic shock or hemodynamic instability
- Stage 4 or greater chronic kidney disease
- Liver disease
- Decompensated cirrhosis
- Alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis
- Decompensated heart failure
- Any other clinically significant disease, per judgement of the investigator
- Neutropenia (neutrophil count \< 1000 cells/cubic mm), thrombocytopenia (platelets \< 50,000/cubic mm) or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \> 3 time the upper limit of normal
- HIV, hepatitis C, hepatitis B infection
- Positive drug screen
- Receipt of chemotherapy, immunosuppressants or immune modulators
- Anti-viral medication
- Any known phage allergy
- Breast feeding or pregnancy
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04787250
Start Date
October 1 2022
End Date
May 1 2024
Last Update
April 4 2022
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905