Bacteriophage Therapy in Patients With Prosthetic Joint Infections
Primary Purpose
Prosthetic Joint Infection
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Phage Therapy
Two-Stage Exchange Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Prosthetic Joint Infection focused on measuring Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint
Eligibility 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1, Phage Therapy with Antibiotic Treatment
Arm 2, Standard of Care
Arm Description
Phage therapy will be administered in conjunction with antibiotic treatment.
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.
Outcomes
Primary Outcome Measures
Safety and tolerability of phage therapy
Incidence and type of adverse events and infusion reactions
Secondary Outcome Measures
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.
Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).
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).
Time to reach minimum clinically important difference in knee injury and osteoarthritis outcome score.
Full Information
NCT ID
NCT04787250
First Posted
February 18, 2021
Last Updated
March 22, 2022
Sponsor
Adaptive Phage Therapeutics, Inc.
Collaborators
Mayo Clinic
1. Study Identification
Unique Protocol Identification Number
NCT04787250
Brief Title
Bacteriophage Therapy in Patients With Prosthetic Joint Infections
Official Title
Randomized Open Label, Parallel Group, Controlled Study to Evaluate the Safety and Surgery Sparing Effect of Phage Therapy With Antibiotics for Patients With Prosthetic Joint Infections Who Are Candidates for Two Stage Exchange Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Changes to protocol design
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adaptive Phage Therapeutics, Inc.
Collaborators
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Joint Infection
Keywords
Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, open-label, parallel-group design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1, Phage Therapy with Antibiotic Treatment
Arm Type
Experimental
Arm Description
Phage therapy will be administered in conjunction with antibiotic treatment.
Arm Title
Arm 2, Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Phage Therapy
Other Intervention Name(s)
Antibiotics
Intervention Description
Phage will be administered based on patient's matching results.
Intervention Type
Procedure
Intervention Name(s)
Two-Stage Exchange Arthroplasty
Other Intervention Name(s)
Antibiotics
Intervention Description
Performed per the study center's standard of care. No investigational products are used.
Primary Outcome Measure Information:
Title
Safety and tolerability of phage therapy
Description
Incidence and type of adverse events and infusion reactions
Time Frame
Day 1 through Week 26
Secondary Outcome Measure Information:
Title
Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.
Description
Proportion of phage-treated patients with no need for surgery by no evidence of a prosthetic joint infection.
Time Frame
6 weeks after completion of phage therapy
Title
Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).
Description
Time to reach minimum clinically important difference in hip dysfunction and osteoarthritis outcome score.
Time Frame
Week 26
Title
Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).
Description
Time to reach minimum clinically important difference in knee injury and osteoarthritis outcome score.
Time Frame
Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Hopkins, MD
Organizational Affiliation
Adaptive Phage Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bacteriophage Therapy in Patients With Prosthetic Joint Infections
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