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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.
To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
Incidence of reactions to study treatment and discontinuation due to adverse events
Time frame: Day 1 through Week 24
Treatment success
No recurrence or evidence of infection with the original pathogen at the same joint
Time frame: 13 months after DAIR
No recurrence or evidence of infection for any reason
Infection due to the original or different pathogen at the index site
Time frame: 3, 6, 13, or 24 months after DAIR
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