Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections

NCT ID: NCT05269121

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-11-30

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.

Conditions

Prosthetic Joint Infection; Bacterial Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DAIR + Phage Treatment + Antibiotics

Phage therapy will be administered in conjunction with antibiotics.

Group Type: EXPERIMENTAL

Phage Therapy

Intervention Type: BIOLOGICAL

Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.

Interventions

Phage Therapy

Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adaptive Phage Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Hopkins, MD

Role: STUDY_CHAIR

Adaptive Phage Therapeutics, Chief Medical Officer

Other Identifiers

APT.PJI.002

Identifier Type: -

Identifier Source: org_study_id