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Sponsor Decision
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAIR + Phage Treatment + Antibiotics | Experimental | Phage therapy will be administered in conjunction with antibiotic treatment. |
|
| DAIR + Placebo + Antibiotics | Placebo Comparator | Placebo will be administered in conjunction with antibiotic treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacteriophage | Drug | Phage Therapy |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Fang, MD | Adaptive Phage Therapeutics, Chief Medical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Medical Center | San Diego | California | 92037 | United States | ||
| Hartford Health Care Bone & Joint Insitute |
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Double-Blind
| Placebo |
| Drug |
Placebo |
|
| 12 months after DAIR |
| Hartford |
| Connecticut |
| 06106 |
| United States |
| Snake River Research | Idaho Falls | Idaho | 83404 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| New England Baptist Hospital | Boston | Massachusetts | 02120 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| WVU Medicine JW Ruby Memorial Hospital | Morgantown | West Virginia | 26506 | United States |