NCT05269121

Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections

An Open-Label Multicenter Study to Evaluate the Safety and Efficacy of PhageBank™ Phage Therapy in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) for Patients With First Time Culture Proven Chronic Prosthetic Joint Infection

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Adaptive Phage Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Phage Therapy	Patient will undergo a DAIR procedure. After the DAIR, phage therapy will be administered in conjunction with antibiotic treatment.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-11-01
• Completion: 2024-11-01
• First posted: 2022-03-07
• Last updated: 2024-02-22

Regulatory

• FDA-regulated drug study