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NCT06605651

PHASE2

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.

Sponsor: Phagenix

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-07

Completion Date

2029-09

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Hip Prosthesis Infection Knee Prosthesis Infection

Interventions

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

Inclusion Criteria: 1. Male or female ≥ 18 years 2. Knee or Hip PJI according to EBJIS (European Bone and Joint Infection) or ICM (International Consensus Meeting) guidelines 3. Monobacterial Infection due to S. aureus 4. 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) 5. 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 6. Indication for Open DAIR decided by the Multidisciplinary Team and/or Principal Investigator 7. 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 8. Patient with a life expectancy of 1 year or more as determined by the principal investigator. 9. Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable effective method of birth control until 1 month after the last study drug administration. 10. Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months) Exclusion Criteria: 1. Relapse between DAIR and study drug administration planned up to 14 days after the DAIR. 2. Patients who have two planned DAIR in sequence (double DAIR) 3. Patients with ASA score ≥ 4 4. Severe sepsis or Septic shock or hemodynamic instability 5. Patients with an indication for fixed prosthesis exchange, or for joint fusion or for amputation 6. Indication for suppressive antibiotherapy 7. 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) 8. Positive Human Immunodeficiency Viruses (HIV) test or active hepatitis B and C 9. Previous treatment by bacteriophages 10. Any known phage allergy and/or to its excipients 11. Elevated ALT or AST above 4 times ULN

Clinical Research Directory

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.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria