Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
- Conditions
- Bacterial InfectionsProsthetic Joint Infection
- Interventions
- Biological: Phage Therapy
- Registration Number
- NCT05269121
- Lead Sponsor
- Adaptive Phage Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DAIR + Phage Treatment + Antibiotics Phage Therapy Phage therapy will be administered in conjunction with antibiotics.
- Primary Outcome Measures
Name Time Method To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection Day 1 through Week 24 Incidence of reactions to study treatment and discontinuation due to adverse events
Treatment success 13 months after DAIR No recurrence or evidence of infection with the original pathogen at the same joint
- Secondary Outcome Measures
Name Time Method No recurrence or evidence of infection for any reason 3, 6, 13, or 24 months after DAIR Infection due to the original or different pathogen at the index site