[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"knee-prosthesis-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:knee-prosthesis-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100562629","phase-2-proof-of-concept-study-to-assess-safety-and-efficacy-of-phage-therapy-in-hip-or-knee-prosthetic-joint-infections-due-to-staphylococcus-aureus-treated-by-dair-100562629",false,"NCT06605651","Proof of Concept Study to Assess Safety and Efficacy of Phage Therapy in Hip or Knee Prosthetic Joint Infections Due to Staphylococcus Aureus Treated by DAIR.","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","GLORIA","Inclusion Criteria:\n\n1. Male or female ≥ 18 years\n2. Knee or Hip PJI according to EBJIS (European Bone and Joint Infection) or ICM (International Consensus Meeting) guidelines\n3. Monobacterial Infection due to S. aureus\n4. Without preoperative diagnosis of superinfection due to another pathogen if treatment is administered at the end of the DAIR (presence of a contaminant is not considered clinically relevant)\n5. Without diagnosis of superinfection due to another pathogen identified within 72h after bacteriological sample performed during the DAIR if treatment is administered up to 14 days after the DAIR\n6. Indication for Open DAIR decided by the Multidisciplinary Team and\u002For Principal Investigator\n7. S. aureus in joint fluid during the pre-inclusion period or in case of relapse of infection under antibiotics therapy in the last 6 months before inclusion\n8. Patient with a life expectancy of 1 year or more as determined by the principal investigator.\n9. Females of childbearing potential\u002FSexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable effective method of birth control until 1 month after the last study drug administration.\n10. Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)\n\nExclusion Criteria:\n\n1. Relapse between DAIR and study drug administration planned up to 14 days after the DAIR.\n2. Patients who have two planned DAIR in sequence (double DAIR)\n3. Patients with ASA score ≥ 4\n4. Severe sepsis or Septic shock or hemodynamic instability\n5. Patients with an indication for fixed prosthesis exchange, or for joint fusion or for amputation\n6. Indication for suppressive antibiotherapy\n7. Immunosuppressed patients: Patients having a weakened immune system due to diseases conditions (i.e. genetic disorders, malnutrition) or treatment (i.e. anticancer drugs or organ transplant)\n8. Positive Human Immunodeficiency Viruses (HIV) test or active hepatitis B and C\n9. Previous treatment by bacteriophages\n10. Any known phage allergy and\u002For to its excipients\n11. Elevated ALT or AST above 4 times ULN","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections (PJI), primarily caused by Staphylococcus aureus and resistant to antibiotics. Standard treatment involves DAIR surgery and antibiotics, but there's a need for better solutions due to rising infections and antibiotic resistance. Bacteriophage therapy, which targets specific bacteria, shows promise. Phaxiam Therapeutics is studying the safety and efficacy of phage therapy in treating Staphylococcus aureus infections in hip or knee PJI patients undergoing DAIR.",[27,28],"Hip Prosthesis Infection","Knee Prosthesis Infection",[30,31,32,33,34,35,36],"Prosthetic Joint Infection","PJI","Bacteriophages","Phages","DAIR","Phage Therapy","Antimicrobials","NOT_YET_RECRUITING","2026-03-31",{"date":40,"type":41},"2026-04-06","ACTUAL",{"date":43,"type":21},"2026-07",{"date":45,"type":21},"2029-09",{"name":47,"class":48},"Phagenix","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100588660","microbiota-as-early-diagnostic-and-predictive-factor-for-osteoarthritic-degeneration-and-microbial-contamination-100588660","NCT06944288","Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination","Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination (MILESTONE)","MILESTONE","Inclusion Criteria:\n\n* proven gut dysbiosis (increased Firmicutes\u002FBacteroidetes (F\u002FB) phyla ratio and increased permeability); age range 18-50 years old.\n* patients undergoing total knee replacement surgery\n* patients undergoing joint revision surgery for septic failure of a knee or hip prostheses; patients undergoing revision surgery for aseptic mobilization for PJI\n\nExclusion Criteria:\n\n* musculoskeletal symptoms; previous shoulder or knee surgery; previous shoulder or knee known pathological conditions; rheumatological diseases\n* any concurrent or previous diseases or conditions which might negatively affect the surgery\n* major predisposing factor for gut dysbiosis (antibiotic therapy in the last 6 months, BMI \\> 40 and inflammatory bowel disease); chronic inflammatory joint diseases (e.g., rheumatoid arthritis, psoriatic arthritis); acute (\\\u003C 90 days after the index procedure) and late hematogenous (symptoms of less than three weeks duration) infections; an inadequate amount of synovial fluid (\\\u003C 10 mL) for culture, WBC, and PMN (neutrophil) percentage determinations","50 Years",{"count":59,"type":21},170,[61],"NA","The patient(s) will participate in a clinical study that aims to investigate how the gut microbiota may influence the proper functioning of joints in the body and how it may affect the development of early osteoarthritis (OA), periprosthetic joint infection (PJI), and recovery after total joint replacement.\n\nIn particular, the prevalence of early OA among patients with gut dysbiosis will be studied (Objective 1). The aim is to identify gut dysbiosis as a potential diagnostic factor for early OA. The study will analyze knee MRI scans and shoulder ultrasound images of 40 patients without musculoskeletal symptoms but with confirmed gut dysbiosis.In addition, the intra-articular microbiota in 50 patients undergoing total knee replacement will be investigated. Serum LPS levels during surgery and fecal microbiota before surgery and during postoperative recovery will be assessed (Objective 2). Postoperative recovery will be assessed based on criteria such as time off crutches and subjective scores.\n\nFinally, this will explore the correlation between gut microbiota and contaminating germs in periprosthetic infections. (Objective 3). 40 patients undergoing joint revision surgery for septic failure of a knee or hip replacement and 40 patients undergoing revision surgery for aseptic loosening for PJI will undergo gut microbiota analysis. Comparison between the two groups will allow evaluation of whether PJI causes changes in the gut microbiota.\n\nThe patients will be included in the study under\n\n* objective 1\n* objective 2\n* objective 3",[64,28,65],"Knee Prosthesis","Disbiosis","2025-04-22",{"date":68,"type":41},"2025-04-25",{"date":70,"type":21},"2026-02-01",{"date":72,"type":21},"2026-05-30",{"name":74,"class":75},"Istituto Clinico Humanitas","OTHER"]