NCT05269134

Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of APT Phage Bank Phage Therapy Versus Placebo in Conjunction With Debridement, Antibiotics, and Implant Retention (DAIR) in Subjects With Chronic Prosthetic Joint Infection (PJI)

• Status: Withdrawn
• Phase: 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 at least 1 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae. This study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + Antibiotics.

Conditions

• Prosthetic Joint Infection

Interventions

Type	Name	Description
DRUG	Bacteriophage	Phage Therapy
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-03-27
• Primary completion: 2025-07-01
• Completion: 2027-07-01
• First posted: 2022-03-07
• Last updated: 2023-11-30

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study