Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Prosthetic Joint Infection

In brief

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

Key facts

Study ID

NCT05269134

Run by

Adaptive Phage Therapeutics, Inc.

People needed

0

Starts

2023-03-27

Expected to finish

2027-07-01

Last updated by the study team

2023-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Diego Medical Center — San Diego, California, United States
• Hartford Health Care Bone & Joint Insitute — Hartford, Connecticut, United States
• Snake River Research — Idaho Falls, Idaho, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• New England Baptist Hospital — Boston, Massachusetts, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• WVU Medicine JW Ruby Memorial Hospital — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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