Bacteriophage Therapy in Patients With Prosthetic Joint Infections

March 22, 2022 updated by: Adaptive Phage Therapeutics, Inc.

Randomized Open Label, Parallel Group, Controlled Study to Evaluate the Safety and Surgery Sparing Effect of Phage Therapy With Antibiotics for Patients With Prosthetic Joint Infections Who Are Candidates for Two Stage Exchange Arthroplasty

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 sp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and/or Klebsiella pneumoniae.

This study will also compare the safety and efficacy of phage therapy in conjunction with antibiotics versus standard of care (SOC) two-stage exchange arthroplasty plus antibiotics.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

General Inclusion Criteria:

  • Males or females ≥18 years of age.
  • Female patients of childbearing potential who agree to use contraception.
  • Candidate for a two-stage exchange arthroplasty.
  • Chronic prosthetic joint infection

General Exclusion Criteria:

  • Prior history of prosthetic joint infections (PJI) of same joint treated surgically other than one prior Debridement Antibiotics and Implant Retention procedure
  • Soft tissue defect requiring reconstruction
  • Hardware misalignment or loosening
  • Active osteomyelitis
  • Septic shock or hemodynamic instability
  • Stage 4 or greater chronic kidney disease
  • Liver disease
  • Decompensated cirrhosis
  • Alcohol abuse or alcohol induced liver disease or non-alcoholic steatohepatitis
  • Decompensated heart failure
  • Any other clinically significant disease, per judgement of the investigator
  • Neutropenia (neutrophil count < 1000 cells/cubic mm), thrombocytopenia (platelets < 50,000/cubic mm) or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 3 time the upper limit of normal
  • HIV, hepatitis C, hepatitis B infection
  • Positive drug screen
  • Receipt of chemotherapy, immunosuppressants or immune modulators
  • Anti-viral medication
  • Any known phage allergy
  • Breast feeding or pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1, Phage Therapy with Antibiotic Treatment
Phage therapy will be administered in conjunction with antibiotic treatment.
Biological: Phage Therapy
Phage will be administered based on patient's matching results.
Other Names:
  • Antibiotics
Active Comparator: Arm 2, Standard of Care
Two-stage exchange arthroplasty entails resection arthroplasty and placement of an antibiotic-loaded spacer, antibiotic therapy, an antibiotic-free observation period, and re-implantation of a new prosthesis.
Procedure: Two-Stage Exchange Arthroplasty
Performed per the study center's standard of care. No investigational products are used.
Other Names:
  • Antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of phage therapy
Time Frame: Day 1 through Week 26
Incidence and type of adverse events and infusion reactions
Day 1 through Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.
Time Frame: 6 weeks after completion of phage therapy
Proportion of phage-treated patients with no need for surgery by no evidence of a prosthetic joint infection.
6 weeks after completion of phage therapy
Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).
Time Frame: Week 26
Time to reach minimum clinically important difference in hip dysfunction and osteoarthritis outcome score.
Week 26
Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).
Time Frame: Week 26
Time to reach minimum clinically important difference in knee injury and osteoarthritis outcome score.
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adaptive Phage Therapeutics, Inc.

Collaborators

Mayo Clinic

Investigators

  • Study Director: Robert J Hopkins, MD, Adaptive Phage Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APT.PJI.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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