Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of APT Phage Bank Phage Therapy Versus Placebo in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) in Subjects With Chronic Prosthetic Joint Infection (PJI)

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.

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.

Inclusion Criteria:

• 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 Criteria:

• 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