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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Single intra-articular injection
Pr Tristan Ferry
Lyon, France
RECRUITINGClinical control of infection at week 12 visit
No Fever, no recurrence, no worsening of pain, no periarticular inflammatory and clinical infectious signs, no new surgical request, no Staphylococcus aureus detected in joint fluid.
Time frame: week 12 visit
Adverse Events and Serious Adverse Events
Incidence, severity and type of adverse events and serious adverse events
Time frame: From the time of signing the informed consent form up to study end visit (Months 24)
Clinical laboratory tests
Number of participants with abnormal clinical laboratory tests
Time frame: From the time of signing the informed consent form up to study end visit (Months 24)
Physical examination
Number of participants with clinically abnormal physical examination findings
Time frame: From the time of signing the informed consent form up to study end visit (Months 24)
Clinical control of infection after Week 12 visit
No Fever, no recurrence, no worsening of pain, no periarticular inflammatory and clinical infectious signs, no new surgical request, no Staphylococcus aureus detected in joint fluid
Time frame: Month 6, Month 12, Month 18 and Month 24.
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