PP-SA-003 - GLORIA
Research type
Research Study
Full 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
IRAS ID
1010112
Contact name
Pascal Birman
Contact email
Sponsor organisation
PHAXIAM Therapeutics
Eudract number
2024-516555-40
Clinicaltrials.gov Identifier
Research summary
A clinical study assessing the safety and efficacy of phage therapy (PP1493 and PP1815) in patients with knee or hip prosthetic joint infection (PJI) due to Staphylococcus aureus, with the indication for DAIR (Debridement Antibiotics and Implant Retention).
Total joint replacement, such as Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA), serve as valuable interventions in managing chronic pain and improving quality of life. However, joint replacements present the challenge of PJIs, with a major cause of PJIs being Staphylococcus aureus. The success rates of PJI treatment vary widely, outlining a significant unmet need in treating PJIs.
Phage therapy could potentially improve the treatment paradigm for PJIs. Based on preclinical and clinical evidence, this therapy has a well-tolerated safety profile. Along with its expected potential efficacy to reduce infection relapse rates, an overall favourable benefit-risk profile is expected for patients in this trial.
The study medication, Anti-Staphylococcus aureus Bacteriophages solutions (PP1493 and PP1815 bacteriophages), are provided to the clinical sites in individual 1mL vials. A fixed-dose combination of both phages diluted in 0.9% sodium chloride will be given to patients once a week for 3 consecutive weeks (Day 0, Day 7, Day 14). Patients will then have a 12 month follow-up period.
During this study period the safety and efficacy of the investigational medicinal product will be evaluated.
The end of Study is defined as the last patient enrolled completing the follow-up period.
Patients will be randomized 1:1 either to the phage therapy arm (PP1493 and PP1815) or to the placebo arm.
Patients will undertake general safety reviews e.g. vital signs, physical examinations, ECGs, and there will be study specific tests e.g. additional blood sampling, patient questionnaires and analysis of joint fluid.
REC name
London - Westminster Research Ethics Committee
REC reference
25/LO/0099
Date of REC Opinion
24 Mar 2025
REC opinion
Further Information Favourable Opinion