Bacteriophage Therapy in Patients With Prosthetic Joint Infections

Randomized Open Label, Parallel Group, Controlled Study to Evaluate the Safety and Surgery Sparing Effect of Phage Therapy With Antibiotics for Patients With Prosthetic Joint Infections Who Are Candidates for Two Stage Exchange Arthroplasty

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 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.

This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.

General Inclusion Criteria:

• 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 Criteria:

• 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