Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

Study Overview
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Brief Summary
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This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.

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 at least 1 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae. This study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + Antibiotics.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of APT Phage Bank Phage Therapy Versus Placebo in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) in Subjects With Chronic Prosthetic Joint Infection (PJI)

Conditions
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Prosthetic Joint Infection

Intervention / Treatment
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* Drug: Bacteriophage
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females ≥18 years of age Recurrent PJI of the knee or hip Female patients of childbearing potential who agree to use contraception. 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 (other than PJI) requiring long term IV antibiotics Unable to tolerate SAT Septic shock or hemodynamic instability Stage 4 or greater chronic kidney disease Liver disease Decompensated heart failure Positive drug screen Receiving chemotherapy Immunocompromised Treatment with antiviral medication within 2 weeks prior to randomization Currently participating in another clinical trial Known phage allergy Pregnant/ breast feeding 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAIR + Phage Treatment + Antibiotics<br>Phage therapy will be administered in conjunction with antibiotic treatment. | Drug: Bacteriophage<br>* Phage Therapy<br>|
| Placebo Comparator: DAIR + Placebo + Antibiotics<br>Placebo will be administered in conjunction with antibiotic treatment. | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI | Incidence of reactions to study treatment and discontinuation due to adverse events | Day 1 through Week 24 | 
| To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI | Time to recurrence or evidence of infection with the original pathogen at the same joint | Day 1 through 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success | No recurrence or evidence of infection with the original pathogen at the same joint | Day 1 through 12 months | 
| No recurrence or evidence of infection for any reason | Infection due to the original pathogen or a different pathogen | 12 months after DAIR | 

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