Using phage therapy to treat joint infections caused by Staphylococcus aureus
A Pilot, Multicenter, Randomized, Non-Comparative, Double-Blind Study of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR and Antibiotic Therapy.
This study is testing if adding a special virus treatment to standard care can help people with long-term joint infections caused by Staphylococcus aureus feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Phaxiam Therapeutics Industry-sponsored |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05369104 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of phage therapy combined with debridement, antibiotics, and salt in treating prosthetic joint infections caused by Staphylococcus aureus. Participants will receive either standard treatment or treatment that includes anti-Staphylococcus aureus bacteriophages. The study aims to assess clinical control of the infection in patients who have had their prosthetic joints infected for over three months. The approach focuses on patients with a specific type of bacterial infection and aims to provide a novel treatment option.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with Staphylococcus aureus infections in knee or hip prostheses that have persisted for more than three months.
Not a fit: Patients with infections caused by multiple pathogens or those without a suitable phage susceptibility profile may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new and effective option for patients suffering from difficult-to-treat joint infections.
How similar studies have performed: While phage therapy is a novel approach in this context, similar studies have shown promise in treating bacterial infections, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female ≥ 18 years 2. Staphylococcus aureus monomicrobial knee or hip PJI ˃3 months after prosthesis implantation with clinical signs of infection and with indication of DAIR with direct closure and Suppressive Antibiotics Therapy (SAT) 3. Staphylococcus aureus only in joint fluid within 6 months before randomization or in case of relapse of infection under antibiotics therapy after a DAIR performed within 6 months before pre-inclusion visit 4. Without preoperative diagnosis of superinfection due to another pathogen 5. Phagogram displaying the susceptibility of the strain to at least one of the phages. 6. Patient with a life expectancy of 2 years and more as determined by the principal investigator 7. Females of childbearing potential/Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 1 month after the last study drug administration 8. Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months) 9. Negative pregnancy test Exclusion Criteria: 1. Early Staphylococcus aureus Prosthesis Joint infection (˂3months after the prosthesis implantation) 2. Other germ found in culture of joint fluid sample 3. Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages 4. Patients with ASA score ≥ 4 5. Severe sepsis or Septic shock or hemodynamic instability 6. Patients with an indication to prosthesis replacement or amputation 7. Immunosuppressed patients 8. ALT or AST \> 5 x ULN, creatinine \> 1.53 mg/dl in men and \> 1.24 mg/dl in women 9. Known allergic reactions to components of phages products 10. Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study 11. Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug 12. Women/Men refusing to use an effective contraception during 1 month after the last administration of study drug.
Where this trial is running
Lyon
- Pr Tristan Ferry — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Alexandra TIZON
- Email: alexandra.tizon@pherecydes-pharma.com
- Phone: +33184861613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.