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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bacteriophages arm | Experimental | 1 mL (PP1493 or PP1815) or 2 mL (PP1493 and PP1815) of suspension of bacteriophages diluted in solution of NaCl 0,9% at the end of DAIR procedure. |
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| Control Arm | Placebo Comparator | One local administration of NaCl 0,9% solution is administered at the end of the DAIR procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-Staphylococcus aureus Bacteriophages | Biological | Single intra-articular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical 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. | week 12 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events and Serious Adverse Events | Incidence, severity and type of adverse events and serious adverse events | From the time of signing the informed consent form up to study end visit (Months 24) |
| Clinical laboratory tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra TIZON | Contact | +33184861613 | alexandra.tizon@pherecydes-pharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pr Tristan Ferry | Recruiting | Lyon | 69004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38066372 | Derived | Ferry T. A Review of Phage Therapy for Bone and Joint Infections. Methods Mol Biol. 2024;2734:207-235. doi: 10.1007/978-1-0716-3523-0_14. |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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This is a pilot, randomized, non-comparative, double-blind study in patients with knee or hip prosthetic joint infection (PJI) due to Staphylococcus aureus, with the indication of DAIR and Suppressive Antibiotics Therapy (SAT). A stratification will be performed on the affected area of arthroplasty: knee or hip and on study site.
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All persons will be blinded, except the pharmacist will be unmasking.
Number of participants with abnormal clinical laboratory tests
| 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 | 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 | Month 6, Month 12, Month 18 and Month 24. |