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
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Primary Endpoint
- To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males or females ≥18 years of age.
- •Stopped or not received SAT for 2 weeks
- •Female patients of childbearing potential who agree to use contraception.
- •First time chronic prosthetic joint infection
- •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
- •Unable to tolerate SAT
- •Septic shock or hemodynamic instability.
- •Chronic kidney disease
- •Liver disease
- •Decompensated heart failure.
- •Positive drug screen
- •Receiving chemotherapy
- •Immunocompromised
- •Antiviral treatment within 2 weeks prior to DAIR
- •Currently participating in another clinical trial
- •Known phage allergy
- •Pregnant/ breastfeeding
- •Lack of capacity to consent
Arms & Interventions
DAIR + Phage Treatment + Antibiotics
Phage therapy will be administered in conjunction with antibiotics.
Intervention: Phage Therapy (Biological)
Outcomes
Primary Outcomes
To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
Time Frame: Day 1 through Week 24
Incidence of reactions to study treatment and discontinuation due to adverse events
Treatment success
Time Frame: 13 months after DAIR
No recurrence or evidence of infection with the original pathogen at the same joint
Secondary Outcomes
- No recurrence or evidence of infection for any reason(3, 6, 13, or 24 months after DAIR)