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Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI) (ACTIVE2)

Primary Purpose

Prosthetic Joint Infection

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bacteriophage
Placebo
Sponsored by
Adaptive Phage Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthetic Joint Infection focused on measuring Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint, DAIR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females ≥18 years of age
  • Recurrent PJI of the knee or hip
  • History of one failed previous surgery for PJI
  • Female patients of childbearing potential who agree to use contraception.
  • Confirmed phage match
  • No anticipated need for long-term antibiotics

Exclusion Criteria:

  • Soft tissue defect requiring reconstruction
  • Hardware misalignment
  • Additional orthopedic hardware in connection with the infected prosthesis
  • Active infection (other than PJI) requiring long term antibiotics
  • Unable to tolerate SAT
  • Septic shock or hemodynamic instability
  • 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
  • Pregnant/ breast feeding
  • Lack of capacity to consent

Sites / Locations

  • Hartford Health Care Bone & Joint InsituteRecruiting
  • Snake River ResearchRecruiting
  • University of Maryland Medical CenterRecruiting
  • Sinai Hospital of BaltimoreRecruiting
  • Brigham & Women's HospitalRecruiting
  • New England Baptist HospitalRecruiting
  • William Beaumont HospitalRecruiting
  • Mayo ClinicRecruiting
  • WVU Medicine JW Ruby Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DAIR + Phage Treatment + Antibiotics

DAIR + Placebo + Antibiotics

Arm Description

Phage therapy will be administered in conjunction with antibiotic treatment.

Placebo will be administered in conjunction with antibiotic treatment.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Treatment success
No recurrence or evidence of infection with the original pathogen at the same joint
No recurrence or evidence of infection for any reason
Infection due to the original pathogen or a different pathogen

Full Information

First Posted
February 25, 2022
Last Updated
October 9, 2023
Sponsor
Adaptive Phage Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05269134
Brief Title
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
Acronym
ACTIVE2
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adaptive Phage Therapeutics, Inc.

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 at least 1 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae. This study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + 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, DAIR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DAIR + Phage Treatment + Antibiotics
Arm Type
Experimental
Arm Description
Phage therapy will be administered in conjunction with antibiotic treatment.
Arm Title
DAIR + Placebo + Antibiotics
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered in conjunction with antibiotic treatment.
Intervention Type
Drug
Intervention Name(s)
Bacteriophage
Intervention Description
Phage Therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
Description
Incidence of reactions to study treatment and discontinuation due to adverse events
Time Frame
Day 1 through Week 24
Title
To evaluate the efficacy of phage + DAIR compared with placebo + DAIR in adult subjects with chronic or recalcitrant PJI
Description
Time to recurrence or evidence of infection with the original pathogen at the same joint
Time Frame
Day 1 through 24 months
Secondary Outcome Measure Information:
Title
Treatment success
Description
No recurrence or evidence of infection with the original pathogen at the same joint
Time Frame
Day 1 through 12 months
Title
No recurrence or evidence of infection for any reason
Description
Infection due to the original pathogen or a different pathogen
Time Frame
12 months after DAIR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Pregnant/ breast feeding Lack of capacity to consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Staci Steele
Phone
(606) 992-0589
Email
SSteele@aphage.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Fang, MD
Organizational Affiliation
Adaptive Phage Therapeutics, Chief Medical Officer
Official's Role
Study Chair
Facility Information:
Facility Name
Hartford Health Care Bone & Joint Insitute
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jake Corsa
Facility Name
Snake River Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Morrison
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Anderson
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Shrestha
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Davis
Facility Name
New England Baptist Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sade Olatunbosun
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tori Ozark
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Bjerke
Facility Name
WVU Medicine JW Ruby Memorial Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Eicher

12. IPD Sharing Statement

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Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

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