knee or hip prosthetic joint infection (PJI) due to Staphylococcus aureus, with the indication of DAIR and Suppressive Antibiotics Therapy (SAT)
Conditions
Brief summary
Clinical control of infection defined by: no clinical signs of evolutive infection: no fever (defined by a temperature less than 38°C) due to prosthesis infection and no recurrence, neither recurrent, nor worsening pain, Peri articular Inflammatory and infectious Clinical signs will be collected : No local post surgical recurrence or worsening of local articular swelling / No unusual aspect of scar as erythema or abnormal flow or a fistula or inflammatory or local necrosis or no healing, No new surgical procedure requested and no Staphylococcus aureus detected
Detailed description
Safety parameters: adverse events, physical examination, biological tests as hematology and biochemistry during the whole study, Initial activity of phages: active bacteriophages (PP1493 and/or PP1815) in regard of the clinical outcome (infection control or relapse) of patients, Clinical control of the infection (as described in primary endpoint) for superinfected patients (other species isolated during the surgical procedure), In case of failure, aspiration of joint fluid at time of failure for microbiological test and identification of Staphylococcus aureus strain: antibiogram, Duration of hospitalization, Questionnaire EQ-5D-5L for quality of life at each visit (except D14±1 and D28±2), Evaluation of joint function with: - Knee: KOOS 12-Knee Survey - Hip: HOOS 12-Hip Survey, Clinical control of the infection (as described in primary endpoint), To check potential appearance of abnormal loosening (border with shifting of the prosthesis) or an abnormal periprosthetic border, In case of rescue treatment: clinical infection control after the first ultra guided injection, safety parameters, pharmacokinetics, bacteriological and immunological tests
Interventions
Sponsors
Phaxiam Therapeutics
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical control of infection defined by: no clinical signs of evolutive infection: no fever (defined by a temperature less than 38°C) due to prosthesis infection and no recurrence, neither recurrent, nor worsening pain, Peri articular Inflammatory and infectious Clinical signs will be collected : No local post surgical recurrence or worsening of local articular swelling / No unusual aspect of scar as erythema or abnormal flow or a fistula or inflammatory or local necrosis or no healing, No new surgical procedure requested and no Staphylococcus aureus detected | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters: adverse events, physical examination, biological tests as hematology and biochemistry during the whole study, Initial activity of phages: active bacteriophages (PP1493 and/or PP1815) in regard of the clinical outcome (infection control or relapse) of patients, Clinical control of the infection (as described in primary endpoint) for superinfected patients (other species isolated during the surgical procedure), In case of failure, aspiration of joint fluid at time of failure for microbiological test and identification of Staphylococcus aureus strain: antibiogram, Duration of hospitalization, Questionnaire EQ-5D-5L for quality of life at each visit (except D14±1 and D28±2), Evaluation of joint function with: - Knee: KOOS 12-Knee Survey - Hip: HOOS 12-Hip Survey, Clinical control of the infection (as described in primary endpoint), To check potential appearance of abnormal loosening (border with shifting of the prosthesis) or an abnormal periprosthetic border, In case of | — |
Countries
France
Outcome results
None listed