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

Hip or Knee prosthetic joint infection due to Staphylococcus aureus

Incidence of serious adverse events up to 3 months, Percentage of Patients with clinical cure up to 3 months

Percentage of patients with clinical cure from S.aureus infection up to 3 months and 12 months. Percentage of patients with relapse exclusively due to another germ than Staphylococcus aureus up to 3 month and 12 months, Incidence of all adverse events and assessment of all safety parameters (Vital signs, ECG/ Echocardiography, hematology, hemostasis and biochemistry) up to 3 months and up to 12 months, Percentage of Patient with clinical cure of PJI and up to 12 months., Titration of anti-S. aureus phage antibodies: -In [redacted] at [redacted] in case of relapse and at Early End Visit if it’s occurred before [redacted] for all patients. -In [redacted] at [redacted] in case of relapse if it’s occurred before [redacted] (all patient) and only for knee PJI patients at [redacted]., Quantitative or Semi-Quantitative Analysis of bacterial load at [redacted] (all patient) and only for knee PJI patient at [redacted]., Quantification and identification of polynuclear of [redacted] at [redacted] (all patients) and [redacted] (only knee PJI)., Number and Duration of hospitalization up to 3 months and up to 12 months, Quality-of-life questionnaires [redacted] at [redacted]., [redacted] Questionnaires at [redacted]., X Ray during [redacted] period and at [redacted] to check potential appearance of abnormal loosening (border with shifting of the prosthesis), periprosthetic border.

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