Bacterial Infections Clinical Trial
Official title:
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. ;
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