Proof of Concept Study to Assess Safety and Efficacy of Phage Therapy in Hip or Knee Prosthetic J… (NCT06605651) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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.
100 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. Without diagnosis of superinfection due to another pathogen identified within 72h after bacteriological sample performed during the DAIR if treatment is administered up to 14 days after the DAIR
✓. Indication for Open DAIR decided by the Multidisciplinary Team and/or Principal Investigator
✓. S. aureus in joint fluid during the pre-inclusion period or in case of relapse of infection under antibiotics therapy in the last 6 months before inclusion
✓. Patient with a life expectancy of 1 year or more as determined by the principal investigator.
Exclusion criteria
✕. 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
✕
What they're measuring
1
To assess the safety of phage therapy + DAIR compared with placebo + DAIR
Timeframe: From enrollment up to 3 months
2
To assess the efficacy of phage therapy + DAIR compared with placebo + DAIR
. Severe sepsis or Septic shock or hemodynamic instability
✕. Patients with an indication for fixed prosthesis exchange, or for joint fusion or for amputation
✕. Indication for suppressive antibiotherapy
✕. Immunosuppressed patients: Patients having a weakened immune system due to diseases conditions (i.e. genetic disorders, malnutrition) or treatment (i.e. anticancer drugs or organ transplant)
✕. Positive Human Immunodeficiency Viruses (HIV) test or active hepatitis B and C