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Bacteriophage Therapy in Patients With Prosthetic Joint Infections

Primary Purpose

Prosthetic Joint Infection

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Phage Therapy
Two-Stage Exchange Arthroplasty
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

Eligibility Criteria

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

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1, Phage Therapy with Antibiotic Treatment

Arm 2, Standard of Care

Arm Description

Phage therapy will be administered in conjunction with antibiotic treatment.

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.

Outcomes

Primary Outcome Measures

Safety and tolerability of phage therapy
Incidence and type of adverse events and infusion reactions

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2021
Last Updated
March 22, 2022
Sponsor
Adaptive Phage Therapeutics, Inc.
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04787250
Brief Title
Bacteriophage Therapy in Patients With Prosthetic Joint Infections
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Changes to protocol design
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

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

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 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.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, open-label, parallel-group design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1, Phage Therapy with Antibiotic Treatment
Arm Type
Experimental
Arm Description
Phage therapy will be administered in conjunction with antibiotic treatment.
Arm Title
Arm 2, Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Phage Therapy
Other Intervention Name(s)
Antibiotics
Intervention Description
Phage will be administered based on patient's matching results.
Intervention Type
Procedure
Intervention Name(s)
Two-Stage Exchange Arthroplasty
Other Intervention Name(s)
Antibiotics
Intervention Description
Performed per the study center's standard of care. No investigational products are used.
Primary Outcome Measure Information:
Title
Safety and tolerability of phage therapy
Description
Incidence and type of adverse events and infusion reactions
Time Frame
Day 1 through Week 26
Secondary Outcome Measure Information:
Title
Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.
Description
Proportion of phage-treated patients with no need for surgery by no evidence of a prosthetic joint infection.
Time Frame
6 weeks after completion of phage therapy
Title
Efficacy of phage therapy in hip joint functionality as assessed by hip disability and osteoarthritis outcome questionnaire score (HOOS).
Description
Time to reach minimum clinically important difference in hip dysfunction and osteoarthritis outcome score.
Time Frame
Week 26
Title
Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).
Description
Time to reach minimum clinically important difference in knee injury and osteoarthritis outcome score.
Time Frame
Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Hopkins, MD
Organizational Affiliation
Adaptive Phage Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Bacteriophage Therapy in Patients With Prosthetic Joint Infections

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