NCT04787250

Bacteriophage Therapy in Patients With Prosthetic Joint Infections

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

• Status: Withdrawn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 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.

Conditions

• Prosthetic Joint Infection

Interventions

Type	Name	Description
BIOLOGICAL	Phage Therapy	Phage will be administered based on patient's matching results.
PROCEDURE	Two-Stage Exchange Arthroplasty	Performed per the study center's standard of care. No investigational products are used.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-05-01
• Completion: 2024-05-01
• First posted: 2021-03-08
• Last updated: 2022-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study