Bacteriophage Therapy in Patients With Prosthetic Joint Infections

NCT04787250 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: APT.PJI.001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prosthetic Joint Infection

Keywords

Prosthetic; Joint; Knee; Hip; Phage; Bacteriophage; Prosthetic Joint

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of phage therapy

  Incidence and type of adverse events and infusion reactions

  Day 1 through Week 26

Secondary Outcomes (3)

• Efficacy of phage therapy to prevent need for surgery in patients with hip/knee prosthetic joint infections.

  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).

  Week 26

• Efficacy of phage therapy in knee joint functionality as assessed by knee injury and osteoarthritis outcome questionnaire score (KOOS).

  Week 26

Study Arms (2)

Arm 1, Phage Therapy with Antibiotic Treatment

EXPERIMENTAL

Phage therapy will be administered in conjunction with antibiotic treatment.

Biological: Phage Therapy

Arm 2, Standard of Care

ACTIVE COMPARATOR

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

Interventions

Phage Therapy BIOLOGICAL

Phage will be administered based on patient's matching results.

Also known as: Antibiotics

Arm 1, Phage Therapy with Antibiotic Treatment

Two-Stage Exchange Arthroplasty PROCEDURE

Performed per the study center's standard of care. No investigational products are used.

Also known as: Antibiotics

Arm 2, Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adaptive Phage Therapeutics, Inc.: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Phage Therapy; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Robert J Hopkins, MD

  Adaptive Phage Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, open-label, parallel-group design

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 8, 2021
• Study Start: October 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)