Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR. (NCT05369104) | Clinical Trial Compass
UnknownPhase 2
Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.
France64 participantsStarted 2022-06-15
Plain-language 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 Infection with an indication of DAIR + SAT.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. Early Staphylococcus aureus Prosthesis Joint infection (˂3months after the prosthesis implantation)
✕. Other germ found in culture of joint fluid sample