Bacteriophage Therapy in Patients With Prosthetic Joint Infections Who Previously Failed Surgery for PJI

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections who have previously failed surgery.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adaptive Phage Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Males or females ≥18 years of age

• Recurrent PJI of the knee or hip

• History of one failed previous surgery for PJI

• 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 antibiotics

• Unable to tolerate SAT

• Septic shock or hemodynamic instability

• 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