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Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

NCT ID: NCT05269134

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2027-07-31

Brief Summary

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This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.

Detailed Description

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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.

Conditions

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Prosthetic Joint Infection

Keywords

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Prosthetic Joint Knee Hip Phage Bacteriophage Prosthetic Joint DAIR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Double-Blind

Study Groups

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DAIR + Phage Treatment + Antibiotics

Phage therapy will be administered in conjunction with antibiotic treatment.

Group Type EXPERIMENTAL

Bacteriophage

Intervention Type DRUG

Phage Therapy

DAIR + Placebo + Antibiotics

Placebo will be administered in conjunction with antibiotic treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Bacteriophage

Phage Therapy

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adaptive Phage Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Fang, MD

Role: STUDY_CHAIR

Adaptive Phage Therapeutics, Chief Medical Officer

Locations

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University of California San Diego Medical Center

San Diego, California, United States

Site Status

Hartford Health Care Bone & Joint Insitute

Hartford, Connecticut, United States

Site Status

Snake River Research

Idaho Falls, Idaho, United States

Site Status

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

New England Baptist Hospital

Boston, Massachusetts, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

WVU Medicine JW Ruby Memorial Hospital

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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APT.PJI.006

Identifier Type: -

Identifier Source: org_study_id