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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
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 sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.
This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1, Phage Therapy with Antibiotic Treatment | Experimental | Phage therapy will be administered in conjunction with antibiotic treatment. |
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| Arm 2, Standard of Care | Active Comparator | Two-stage exchange arthroplasty entails resection arthroplasty and placement of an antibiotic-loaded spacer, antibiotic therapy, an antibiotic-free observation period, and re-implantation of a new prosthesis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phage Therapy | Biological | Phage will be administered based on patient's matching results. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of phage therapy | Incidence and type of adverse events and infusion reactions | Day 1 through Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections. | Proportion of phage-treated patients with no need for surgery by no evidence of a prosthetic joint infection. | 6 weeks after completion of phage therapy |
| Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS). |
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General Inclusion Criteria:
General Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Hopkins, MD | Adaptive Phage Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D000071059 | Phage Therapy |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
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randomized, open-label, parallel-group design
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| Two-Stage Exchange Arthroplasty | Procedure | Performed per the study center's standard of care. No investigational products are used. |
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Time to reach minimum clinically important difference in hip dysfunction and osteoarthritis outcome score. |
| Week 26 |
| Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS). | Time to reach minimum clinically important difference in knee injury and osteoarthritis outcome score. | Week 26 |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |