Study Stopped
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Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
ACTIVE2
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of APT Phage Bank Phage Therapy Versus Placebo in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) in Subjects With Chronic Prosthetic Joint Infection (PJI)
1 other identifier
interventional
N/A
1 country
10
Brief Summary
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2023
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2022
CompletedFirst Posted
Study publicly available on registry
March 7, 2022
CompletedStudy Start
First participant enrolled
March 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedNovember 30, 2023
October 1, 2023
2.3 years
February 25, 2022
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
Treatment success
Day 1 through 12 months
No recurrence or evidence of infection for any reason
12 months after DAIR
Study Arms (2)
DAIR + Phage Treatment + Antibiotics
EXPERIMENTALPhage therapy will be administered in conjunction with antibiotic treatment.
DAIR + Placebo + Antibiotics
PLACEBO COMPARATORPlacebo will be administered in conjunction with antibiotic treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Males or females ≥18 years of age
- Recurrent PJI of the knee or hip
- Female patients of childbearing potential who agree to use contraception.
- Confirmed phage match
- No anticipated need for long-term antibiotics
You may not qualify if:
- Soft tissue defect requiring reconstruction
- Hardware misalignment
- Additional orthopedic hardware in connection with the infected prosthesis
- Active infection (other than PJI) requiring long term IV antibiotics
- Unable to tolerate SAT
- Septic shock or hemodynamic instability
- Stage 4 or greater chronic kidney disease
- Liver disease
- Decompensated heart failure
- Positive drug screen
- Receiving chemotherapy
- Immunocompromised
- Treatment with antiviral medication within 2 weeks prior to randomization
- Currently participating in another clinical trial
- Known phage allergy
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of California San Diego Medical Center
San Diego, California, 92037, United States
Hartford Health Care Bone & Joint Insitute
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
Study Officials
- STUDY CHAIR
Edward Fang, MD
Adaptive Phage Therapeutics, Chief Medical Officer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2022
First Posted
March 7, 2022
Study Start
March 27, 2023
Primary Completion
July 1, 2025
Study Completion (Estimated)
July 1, 2027
Last Updated
November 30, 2023
Record last verified: 2023-10