About this trial
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.
Eligibility criteria
Qualifiers
Male or female ≥ 18 years
Knee or Hip PJI according to EBJIS (European Bone and Joint Infection) or ICM (International Consensus Meeting) guidelines
Monobacterial Infection due to S. aureus
Without preoperative diagnosis of superinfection due to another pathogen if treatment is administered at the end of the DAIR (presence of a contaminant is not considered clinically relevant)
Disqualifiers
Relapse between DAIR and study drug administration planned up to 14 days after the DAIR.
Patients who have two planned DAIR in sequence (double DAIR)
Patients with ASA score ≥ 4
Severe sepsis or Septic shock or hemodynamic instability
Trial design
Treatments tested in this trial
- Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution
- 0.9% NaCl solution