Status:
UNKNOWN
Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.
Lead Sponsor:
Phaxiam Therapeutics
Conditions:
Infection of Total Hip Joint Prosthesis
Infection of Total Knee Joint Prosthesis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Pilot non comparative study assessing the clinical control of infection of DAIR + SAT +NaCl and DAIR + SAT + Phages anti-Staphylococcus aureus in patients with Staphylococcus aureus Prosthetic Joint I...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years
- 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)
- 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
- Without preoperative diagnosis of superinfection due to another pathogen
- Phagogram displaying the susceptibility of the strain to at least one of the phages.
- Patient with a life expectancy of 2 years and more as determined by the principal investigator
- 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
- Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)
- Negative pregnancy test
Exclusion
- Early Staphylococcus aureus Prosthesis Joint infection (˂3months after the prosthesis implantation)
- Other germ found in culture of joint fluid sample
- Phagogram displaying no susceptibility of the strain to anti-Staphylococcus aureus bacteriophages
- Patients with ASA score ≥ 4
- Severe sepsis or Septic shock or hemodynamic instability
- Patients with an indication to prosthesis replacement or amputation
- Immunosuppressed patients
- ALT or AST \> 5 x ULN, creatinine \> 1.53 mg/dl in men and \> 1.24 mg/dl in women
- Known allergic reactions to components of phages products
- Medical history which in the opinion of the investigator would mean that the patient is unsuitable for participation in the study
- 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
- Women/Men refusing to use an effective contraception during 1 month after the last administration of study drug.
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 16 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05369104
Start Date
June 15 2022
End Date
June 16 2025
Last Update
June 22 2022
Active Locations (1)
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1
Pr Tristan Ferry
Lyon, France, 69004