Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
- Registration Number
- NCT05269134
- Lead Sponsor
- Adaptive Phage Therapeutics, Inc.
- 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 aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae.
This study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + Antibiotics.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DAIR + Phage Treatment + Antibiotics Bacteriophage Phage therapy will be administered in conjunction with antibiotic treatment. DAIR + Placebo + Antibiotics Placebo Placebo will be administered in conjunction with antibiotic treatment.
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI Day 1 through Week 24 Incidence of reactions to study treatment and discontinuation due to adverse events
To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI Day 1 through 24 months Time to recurrence or evidence of infection with the original pathogen at the same joint
- Secondary Outcome Measures
Name Time Method Treatment success Day 1 through 12 months No recurrence or evidence of infection with the original pathogen at the same joint
No recurrence or evidence of infection for any reason 12 months after DAIR Infection due to the original pathogen or a different pathogen
Trial Locations
- Locations (10)
Hartford Health Care Bone & Joint Insitute
🇺🇸Hartford, Connecticut, United States
Snake River Research
🇺🇸Idaho Falls, Idaho, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
New England Baptist Hospital
🇺🇸Boston, Massachusetts, United States
WVU Medicine JW Ruby Memorial Hospital
🇺🇸Morgantown, West Virginia, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States