Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections

An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection

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 infection (PJI) without replacement of the prosthesis.

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 spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.

This study will compare the safety and efficacy of phage therapy in conjunction with standard of care antibiotics and a DAIR procedure.

Inclusion Criteria:

• 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 Criteria:

• 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