Bacteriophage Therapy in Patients With Prosthetic Joint Infections
NCT ID: NCT04787250
Last Updated: 2022-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2022-10-31
2024-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1, Phage Therapy with Antibiotic Treatment
Phage therapy will be administered in conjunction with antibiotic treatment.
Phage Therapy
Phage will be administered based on patient's matching results.
Arm 2, Standard of Care
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.
Two-Stage Exchange Arthroplasty
Performed per the study center's standard of care. No investigational products are used.
Interventions
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Phage Therapy
Phage will be administered based on patient's matching results.
Two-Stage Exchange Arthroplasty
Performed per the study center's standard of care. No investigational products are used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female patients of childbearing potential who agree to use contraception.
* Candidate for a two-stage exchange arthroplasty.
* Chronic prosthetic joint infection
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Adaptive Phage Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert J Hopkins, MD
Role: STUDY_DIRECTOR
Adaptive Phage Therapeutics
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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APT.PJI.001
Identifier Type: -
Identifier Source: org_study_id
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