Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prosthetic Joint Infection, Bacterial Infections

Intervention / Treatment
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* Biological: Phage Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAIR + Phage Treatment + Antibiotics<br>Phage therapy will be administered in conjunction with antibiotics. | Biological: Phage Therapy<br>* Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 1 through Week 24 | 
| Treatment success | No recurrence or evidence of infection with the original pathogen at the same joint | 13 months after DAIR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No recurrence or evidence of infection for any reason | Infection due to the original or different pathogen at the index site | 3, 6, 13, or 24 months after DAIR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Prosthetic, Joint, Knee, Phage, Bacteriophage, Prosthetic Joint, DAIR