NCT06605651

Proof of Concept Study to Assess Safety and Efficacy of Phage Therapy in Hip or Knee Prosthetic Joint Infections Due to Staphylococcus Aureus Treated by DAIR.

A Phase II Proof of Concept Multicenter, Randomized, Double-Blind Study to Assess the Safety and Efficacy of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated by DAIR

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Phagenix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections (PJI), primarily caused by Staphylococcus aureus and resistant to antibiotics. Standard treatment involves DAIR surgery and antibiotics, but there's a need for better solutions due to rising infections and antibiotic resistance. Bacteriophage therapy, which targets specific bacteria, shows promise. Phaxiam Therapeutics is studying the safety and efficacy of phage therapy in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR.

Detailed description

Total joint replacement serves as valuable interventions in the management of chronic refractory pain when the other conservative treatments have not worked. They play a vital role in alleviating discomfort and improving the quality of life of subjects battling with joint diseases. However, the joint replacements present the challenge of Prosthetic Joint Infection (PJI). PJI have serious complications and can lead to significant mortality, morbidity, and healthcare expenditure. The leading cause of PJI is gram-positive cocci, specifically Staphylococcus aureus. Bacterial biofilms, mainly formed with Staphylococcus, represent a significant challenge in the treatment of PJIs due to their resistance to antibiotic therapy. Standard of Care (SOC) for these complex infections is characterized primarily by an initial surgery (Debridment Antibiotics and Implant Retention (DAIR) and various regiments and combinations of antibiotics. While the patterns of utilization vary between institutions and geography, DAIR is considered low-invasive procedure, characterized by the possibility of not explanting the prosthetic implant and resecting the bone. The growing demand for joint arthroplasty and current PJI rates, combined with antibacterial resistance, clearly indicate an unmet medical need in treating biofilm-based PJIs. Bacteriophage therapy could potentially improve the treatment paradigm for PJIs. Bacteriophages naturally occur with highly specific bacterial viruses that infiltrate bacterial cells, disrupting their metabolism, and causing bacterial lysis. Initial in vivo studies of phage therapy for bone-related infections have shown promise. Phaxiam Therapeutics, a biotechnology company specializing in the research and development of anti-infective therapies using bacteriophages., has collections of phages against Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. These phages have shown promise in preliminary tests and studies. The objective of GLORIA study Is to assess the safety and efficacy of phage therapy versus placebo in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR.

Conditions

• Hip Prosthesis Infection
• Knee Prosthesis Infection

Interventions

Type	Name	Description
BIOLOGICAL	Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution	Three intra-articular injections during and/or following DAIR procedure
DRUG	0.9% NaCl solution	Three intra-articular injections during and/or following DAIR procedure

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-03-01
• Completion: 2029-09-01
• First posted: 2024-09-20
• Last updated: 2026-04-06

Regulatory

• FDA-regulated drug study