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Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections (ACTIVE1)

Primary Purpose

Prosthetic Joint Infection, Bacterial Infections

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Phage Therapy
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.
  • 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

Exclusion Criteria:

  • 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
  • Pregnant/ breastfeeding
  • Lack of capacity to consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DAIR + Phage Treatment + Antibiotics

    Arm Description

    Phage therapy will be administered in conjunction with antibiotics.

    Outcomes

    Primary Outcome Measures

    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
    Treatment success
    No recurrence or evidence of infection with the original pathogen at the same joint

    Secondary Outcome Measures

    No recurrence or evidence of infection for any reason
    Infection due to the original or different pathogen at the index site

    Full Information

    First Posted
    February 25, 2022
    Last Updated
    March 8, 2022
    Sponsor
    Adaptive Phage Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05269121
    Brief Title
    Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
    Acronym
    ACTIVE1
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2024 (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 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.
    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 1 or 2 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae. This study will compare the safety and efficacy of phage therapy in conjunction with standard of care antibiotics and a DAIR procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prosthetic Joint Infection, Bacterial Infections
    Keywords
    Prosthetic, Joint, Knee, Hip, Phage, Bacteriophage, Prosthetic Joint, DAIR

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (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 antibiotics.
    Intervention Type
    Biological
    Intervention Name(s)
    Phage Therapy
    Intervention Description
    Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.
    Primary Outcome Measure Information:
    Title
    To evaluate safety and tolerability of phage therapy in adult patients undergoing DAIR for first time chronic prosthetic knee or hip infection
    Description
    Incidence of reactions to study treatment and discontinuation due to adverse events
    Time Frame
    Day 1 through Week 24
    Title
    Treatment success
    Description
    No recurrence or evidence of infection with the original pathogen at the same joint
    Time Frame
    13 months after DAIR
    Secondary Outcome Measure Information:
    Title
    No recurrence or evidence of infection for any reason
    Description
    Infection due to the original or different pathogen at the index site
    Time Frame
    3, 6, 13, or 24 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. 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 Exclusion Criteria: 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 Pregnant/ breastfeeding Lack of capacity to consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stephanie Holland
    Phone
    202-391-8058
    Email
    sholland@aphage.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Hopkins, MD
    Organizational Affiliation
    Adaptive Phage Therapeutics, Chief Medical Officer
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections

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