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.
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)
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
Parallel
Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution
Biological/VaccineThree intra-articular injections during and/or following DAIR procedure
0.9% NaCl solution
DrugThree intra-articular injections during and/or following DAIR procedure
To assess the safety of phage therapy + DAIR compared with placebo + DAIR
Incidence of serious adverse events
To assess the efficacy of phage therapy + DAIR compared with placebo + DAIR
Percentage of patients with clinical cure
To assess the safety of phage therapy + DAIR compared with placebo + DAIR
Incidence of all adverse events and all safety parameters
To assess the efficacy of phage therapy + DAIR compared with placebo + DAIR
Percentage of Patient with clinical cure from S.aureus's infection up to 6 months and up to 12 months. Percentage of patients with relapse exclusively due to another germ than Staphylococcus aureus up to 3 months, 6 months and 12 months
To describe the immunological response in serum and in joint fluid
Titration of anti-Staphylococcus aureus phage antibodies
To describe the S. aureus bacterial load (bacteriology) in the joint fluid up to 1 month
Quantitative or Semi-Quantitative analysis of bacterial load
This trial is not recruiting at the moment. You can still explore other options:
