Prosthetic Joint Infection
Conditions
Keywords
Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint
Brief summary
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
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 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.
Interventions
BIOLOGICALPhage Therapy
Phage will be administered based on patient's matching results.
PROCEDURETwo-Stage Exchange Arthroplasty
Performed per the study center's standard of care. No investigational products are used.
Sponsors
Mayo Clinic
Adaptive Phage Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized, open-label, parallel-group design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: * Males or females ≥18 years of age. * Female patients of childbearing potential who agree to use contraception. * Candidate for a two-stage exchange arthroplasty. * Chronic prosthetic joint infection General
Exclusion criteria
* Prior history of prosthetic joint infections (PJI) of same joint treated surgically other than one prior Debridement Antibiotics and Implant Retention procedure * Soft tissue defect requiring reconstruction * Hardware misalignment or loosening * Active osteomyelitis * Septic shock or hemodynamic instability * Stage 4 or greater chronic kidney disease * Liver disease * Decompensated cirrhosis * Alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis * Decompensated heart failure * Any other clinically significant disease, per judgement of the investigator * Neutropenia (neutrophil count \< 1000 cells/cubic mm), thrombocytopenia (platelets \< 50,000/cubic mm) or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \> 3 time the upper limit of normal * HIV, hepatitis C, hepatitis B infection * Positive drug screen * Receipt of chemotherapy, immunosuppressants or immune modulators * Anti-viral medication * Any known phage allergy * Breast feeding or pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of phage therapy | Day 1 through Week 26 | Incidence and type of adverse events and infusion reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections. | 6 weeks after completion of phage therapy | Proportion of phage-treated patients with no need for surgery by no evidence of a prosthetic joint infection. |
| Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS). | Week 26 | Time to reach minimum clinically important difference in hip dysfunction and osteoarthritis outcome score. |
| Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS). | Week 26 | Time to reach minimum clinically important difference in knee injury and osteoarthritis outcome score. |
Countries
United States
Outcome results
None listed