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.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhagenix

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

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators