Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
Launched by ADAPTIVE PHAGE THERAPEUTICS, INC. · Feb 25, 2022
Trial Information
Current as of May 24, 2025
Withdrawn
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About Adaptive Phage Therapeutics, Inc.
Adaptive Phage Therapeutics, Inc. is an innovative biotechnology company focused on advancing the field of phage therapy to combat antibiotic-resistant infections. By harnessing the therapeutic potential of bacteriophages—viruses that specifically target and kill bacteria—Adaptive Phage Therapeutics aims to develop personalized treatment solutions that address the growing global health threat posed by multidrug-resistant pathogens. The company is dedicated to rigorous clinical research and development, collaborating with healthcare professionals and regulatory bodies to bring effective, safe, and tailored phage-based therapies to patients in need.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Boston, Massachusetts, United States
Royal Oak, Michigan, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
San Diego, California, United States
Boston, Massachusetts, United States
Idaho Falls, Idaho, United States
Hartford, Connecticut, United States
Morgantown, West Virginia, United States
Patients applied
Trial Officials
Edward Fang, MD
Study Chair
Adaptive Phage Therapeutics, Chief Medical Officer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials