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Virus Therapy
Phage Therapy for Prosthetic Joint Infections
Phase 1 & 2
Waitlist Available
Research Sponsored by Adaptive Phage Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through week 26
Awards & highlights
No Placebo-Only Group
Summary
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
Eligible Conditions
- Prosthetic Joint Infections
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through week 26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability of phage therapy
Secondary study objectives
Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).
Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).
Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1, Phage Therapy with Antibiotic TreatmentExperimental Treatment1 Intervention
Phage therapy will be administered in conjunction with antibiotic treatment.
Group II: Arm 2, Standard of CareActive Control1 Intervention
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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Who is running the clinical trial?
Adaptive Phage Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
127 Total Patients Enrolled
2 Trials studying Prosthetic Joint Infections
Mayo ClinicOTHER
3,350 Previous Clinical Trials
3,060,674 Total Patients Enrolled
1 Trials studying Prosthetic Joint Infections
4,618 Patients Enrolled for Prosthetic Joint Infections
Robert J Hopkins, MDStudy DirectorAdaptive Phage Therapeutics
1 Previous Clinical Trials
1 Total Patients Enrolled
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