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Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
ACTIVE1
An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This study will test the feasibility of a regimen of intraoperative (IO) and intravenous (IV) PhageBank™ bacteriophage therapy in conjunction with a DAIR procedure to cure chronic prosthetic joint infection (PJI) without replacement of the prosthesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2022
Typical duration for phase_1
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
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedFebruary 22, 2024
February 1, 2024
1.2 years
February 25, 2022
February 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
Incidence of reactions to study treatment and discontinuation due to adverse events
Day 1 through Week 24
Treatment success
No recurrence or evidence of infection with the original pathogen at the same joint
13 months after DAIR
Secondary Outcomes (1)
No recurrence or evidence of infection for any reason
3, 6, 13, or 24 months after DAIR
Study Arms (1)
DAIR + Phage Treatment + Antibiotics
EXPERIMENTALPhage therapy will be administered in conjunction with antibiotics.
Interventions
Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.
Eligibility Criteria
You may qualify if:
- Males or females ≥18 years of age.
- Stopped or not received SAT for 2 weeks
- Female patients of childbearing potential who agree to use contraception.
- First time chronic prosthetic joint infection
- 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
- Unable to tolerate SAT
- Septic shock or hemodynamic instability.
- Chronic kidney disease
- Liver disease
- Decompensated heart failure.
- Positive drug screen
- Receiving chemotherapy
- Immunocompromised
- Antiviral treatment within 2 weeks prior to DAIR
- Currently participating in another clinical trial
- Known phage allergy
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert Hopkins, MD
Adaptive Phage Therapeutics, Chief Medical Officer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2022
First Posted
March 7, 2022
Study Start
September 1, 2022
Primary Completion
November 1, 2023
Study Completion
November 1, 2024
Last Updated
February 22, 2024
Record last verified: 2024-02