[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"staphylococcus-aureus-bacteremia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:staphylococcus-aureus-bacteremia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,52,81,109,137,163,192,213,240],{"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":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100565065","phase-4-daptomycin-vs-vancomycin-for-the-treatment-of-methicillin-resistant-s-aureus-bacteremia-100565065",false,"NCT06637332","Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia","DAPTO-SNAP: Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia","DAPTO-SNAP","The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:\n\nInclusion Criteria:\n\n* Methicillin-resistant S. aureus bacteremia\n\nExclusion Criteria:\n\n* Severe allergy or non-severe rash to vancomycin or daptomycin\n* Suspected or confirmed MRSA pneumonia\n* Known vancomycin minimum inhibitory concentration (MIC) greater than or equal to 2mg\u002FL or daptomycin MIC greater than or equal to 1mg\u002FL","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is an open label randomized controlled trial for patients with methicillin resistant S. aureus (MRSA) bloodstream infection which will directly compare the two most commonly used therapies, vancomycin and daptomycin.\n\nThis study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119)",[27,28,29,30,31],"Staphylococcus Aureus Septicemia","Staphylococcus Aureus Bacteremia","S. Aureus Bacteremia","S. Aureus Bloodstream Infection","Staphylococcus Aureus Endocarditis",[33,34,35,36,37,38],"S. aureus bacteremia","Methicllin resistant","MRSA","S. aureus bloodstream infection","Daptomycin","Vancomycin","RECRUITING","2026-06-18",{"date":42,"type":43},"2026-06-22","ACTUAL",{"date":45,"type":43},"2024-11-14",{"date":47,"type":21},"2027-11",{"name":49,"class":50},"Todd C. Lee MD MPH FIDSA","OTHER",17,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100430531","phase-2-combination-cefazolin-with-ertapenem-for-methicillin-susceptible-staphylococcus-aureus-bacteremia-100430531","NCT04886284","Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia","Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia (CERT)","CERT","The participant must fulfil all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria to be eligible for this sub-study:\n\nInclusion Criteria:\n\n1. Adult \\>=18 years old\n2. S. aureus bacteremia within the past 48 hours:\n\n   * with any unknown MRSA status (in centers with \\\u003C15% prevalence of MRSA in their annual blood cultures) or known negative MRSA screening swab within 90 days OR\n   * which has already been shown to be MSSA\n3. Current receipt of cefazolin or where it would be clinically appropriate (according to treating ID specialist) to switch to cefazolin as the backbone therapy (open label, non-study drug).\n\nNOTE: Up to an additional 12-24 hours of open label non-study VANCOMYCIN, LINEZOLID or DAPTOMYCIN may be allowed if there is sepsis and clinical concern for MRSA has not been excluded.\n\nExclusion Criteria:\n\nClinical:\n\n1. At time of recruitment, the patient has already clinically improved with at least one subsequent negative culture at \\>24 hours incubation\n2. Anaphylaxis to any beta-lactam antibiotic (and any allergy to ertapenem) Polymicrobial bacteremia (not including skin commensals)\n3. Known seizure disorder\n4. Any receipt of valproic acid\n5. Expected mortality within 48 hours\n6. Need for critical care resources but \"do not resuscitate\" status precludes the receipt of critical care\n7. Unable to provide informed consent and no available healthcare proxy (with ethics approval for deferred consent in cases of severe illness)\n\nAdministrative:\n\n1. Refusal to provide informed consent\n2. Refusal of healthcare team to participate\n3. No reliable means of outpatient contact (telephone\u002Femail\u002Ftext)\n4. Previously enrolled\n5. Patients whose isolate is identified as MRSA post-enrollment will be subsequently excluded (see below).\n\nNote that because MSSA is much more common than MRSA in Canada (90% of all S. aureus bacteremia at MUHC, for example, are MSSA and in the presence of a negative MRSA screening swab or unknown MRSA status, this means that the risk of MRSA is less than 5%). We believe time to combination therapy is likely linked to benefit, therefore we will recruit the patients as soon as S. aureus is identified but potentially prior to confirmation the organism is MSSA. Where possible, rapid MRSA detection techniques will be deployed; however with conventional screening this will mean approximately a 12-24 hours delay. Organisms subsequently identified as MRSA will be excluded from the intention to treat analysis and the sample size will be adjusted accordingly to ensure the total enrollment meets study goals.","100 Years",{"count":62,"type":21},60,[64],"PHASE2","There is a variety of in vitro, in vivo (animal model), and human case series data which suggests that the addition of ertapenem to cefazolin could improve outcomes in methicillin-susceptible S. aureus bacteremia. No randomized controlled trial has been performed.\n\nThis study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119)",[28,27,67,31],"Staphylococcal Sepsis",[69,70,71],"Staphylococcus aureus","Methicillin-susceptible","Bacteremia","2026-05-22",{"date":74,"type":43},"2026-05-27",{"date":76,"type":43},"2024-05-20",{"date":78,"type":21},"2027-07",{"name":49,"class":50},6,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100449794","phase-4-staphylococcus-aureus-network-adaptive-platform-trial-100449794","NCT05137119","Staphylococcus Aureus Network Adaptive Platform Trial","SNAP","PLATFORM Inclusion Criteria:\n\nPatients must fulfil all of the following criteria to be eligible to enter the SNAP trial:\n\n1. Staphylococcus aureus complex grown from ≥1 blood culture\n2. Admitted to a participating hospital at the time of eligibility assessment (OR if patient has died, they were admitted to this site anytime from the time of blood culture collection until the time of eligibility assessment)\n\nPLATFORM Exclusion Criteria:\n\nPotentially eligible participants meeting any of the following criteria at the time of eligibility assessment for platform entry will be excluded from the randomised platform (but may still participate in the registry):\n\n1. Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture (Where the time of culture collection is not recorded, the time of laboratory registration of the sample will be used as an alternative)\n2. Polymicrobial bacteraemia, defined as more than one organism (at species level) in the index blood cultures OR in any subsequent blood culture reported between the collection of the index blood culture and platform eligibility assessment, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician.\n3. Known previous participation in the randomised SNAP platform\n4. Known positive blood culture for S. aureus (of the same silo: PSSA, MSSA or MRSA) between 72 hours and 180 days prior to the time of eligibility assessment\n5. Treating team deems enrolment in the study is not in the best interest of the patient\n6. Treating team believes that death is imminent and inevitable\n7. Patient is for end-of-life care and antibiotic treatment is considered not appropriate\n8. Patient \\\u003C18 years of age and paediatric recruitment not approved at recruiting site\n9. Patient has died since the collection of the index blood culture\n\nTo be included in any of the following DOMAINS the participant must met eligible for the PLATFORM (as listed above)\n\nADJUNCTIVE TREATMENT DOMAIN\n\nInclusion Criteria:\n\n1. All participants that met the PLATFORM eligible are eligible to be included in this domain unless they meet any of the following exclusions listed.\n2. Patients are eligible for this domain regardless of S. aureus susceptibility testing results to clindamycin.\n\nExclusion criteria:\n\n1\\. Previous type 1 hypersensitivity reaction to lincosamides 2. Currently receiving clindamycin (lincomycin) or linezolid which cannot be ceased or substituted 3. Necrotising fasciitis 4. Current C. difficile associated diarrhoea (any severity) 5. Current severe diarrhoea from any cause (defined as Grade 3 or higher) 5. Known CDAD (C.Difficile Associated Diarrhoea) in the past 3 months, or CDAD relapse in the past 12 months 6. At the time of domain eligibility assessment, more than 4 hours has elapsed since platform entry 7. Treating clinician deems enrolment in this domain is not in the best interest of the patient\n\nPSSA, MSSA TREATMENT DOMAIN (backbone)\n\nInclusion Criteria:\n\n1. For PSSA silo: Index blood culture isolate is penicillin-susceptible as per the Microbiology Appendix. In short, this will require phenotypic disc testing with EUCAST (a P1 disc diffusion with zone \\>=26mm OR a P1 disc diffusion with zone \\>=26mm and the zone edge is NOT sharp) OR CLSI (a P10 disc diffusion) defined criteria.\n2. For MSSA silo: Index blood culture isolate is methicillin-susceptible as per the Microbiology Appendix.\n\nNote that where trial sites are not testing for penicillin-susceptibility, patients with MSSA\u002FPRSA can be included in the MSSA silo, but those with MSSA\u002FPSSA (but not confirmed with a P-disc) will be excluded from the backbone domain. The rationale for this is that patients with MSSA but not tested with a P-disc may be truly PSSA (with no blaZ). If the cefazolin inoculum effect (CIE) is a clinically relevant entity, then including patients with an organism without blaZ (and hence cannot have a CIE phenotype), will bias towards non-inferiority of cefazolin compared to (flu)cloxacillin.\n\nFor PSSA, the requirement for laboratories to use an accredited phenotypic test for a penicillin-susceptible phenotype, is to ensure clinical safety according to internationally accepted guidelines. The automated antimicrobial susceptibility testing, and other phenotypic tests, have poor sensitivity for detection of blaZ compared to a gold standard of blaZ PCR. Therefore, patients could be placed at risk of treatment with benzylpenicillin when the infecting isolate is actually blaZ positive, unless these guidelines are followed.\n\nExclusion Criteria (PSSA \\& MSSA):\n\n1. \\>72 hours have elapsed since the collection of the index blood culture (i.e. the time of collection of the first positive blood culture from the patient during this episode)\n2. History of type I hypersensitivity reaction (i.e. anaphylaxis or angioedema) to any penicillin or cephalosporin\n3. History of severe delayed reaction (e.g. allergic interstitial nephritis, cutaneous vasculitis, Stevens-Johnson, DRESS, etc.) to any penicillin or cephalosporin\n4. PSSA silo: Non-severe rash to any penicillin (unless patient has been subsequently de-labelled; this criteria does not include criteria 2 and 3 above), or MSSA silo: Non-severe rash to cefazolin or any penicillin (unless patient has been subsequently de-labelled); (Nausea, diarrhoea, headache, and other non-specific symptoms are NOT allergies, they are drug intolerance, and they are not exclusion criteria. Similarly, a vague history of an allergy of unclear nature, or a family history of allergy are not exclusions.)\n5. Treating team deems enrolment in this domain is not in the best interest of the patient\n6. Currently receiving maintenance dialysis (haemodialysis or peritoneal dialysis); (Acute renal replacement therapy (including CRRT, haemodialysis or peritoneal dialysis) are not exclusions. Such patients are eligible as long as appropriate vascular access is available or can be arranged.)\n7. Polymicrobial bacteraemia (defined as more than one organism \\[at species level\\] in blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician) reported between collection of the index blood culture and backbone domain eligibility assessment\n8. Patient currently being treated with a systemic antibacterial agent that cannot be ceased or substituted for interventions allocated within the platform (unless antibiotic is listed in Table 1 of the DSA, which specifies allowed antibiotics with limited absorption from the gastrointestinal tract or negligible antimicrobial activity against S. aureus)\n\nMRSA TREATMENT DOMAIN (backbone)\n\nInclusion Criteria:\n\n1\\. MRSA confirmed microbiologically\n\nExclusion Criteria:\n\n1. Time to allocation reveal is \\>72 hours from time of index blood culture collection\n2. Severe allergy to any beta-lactam (including cefazolin) Immediate severe allergy: Anaphylaxis\u002Fangioedema Severe delayed allergy: Severe cutaneous adverse reaction (SCAR; including Steven Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP)), severe drug induced liver injury, proven allergic interstitial nephritis, immune-mediated haemolytic anaemia and other severe cytopenia.\n3. Non-severe rash to cefazolin Nausea, diarrhoea, headache and other non-specific symptoms are NOT allergies, they are drug intolerance, and they are not exclusion criteria. Similarly, a vague history of an allergy of unclear nature, or a family history of allergy are not exclusions.)\n\n3\\. Severe allergy or non-severe rash to both vancomycin AND daptomycin Vancomycin infusion reaction (formerly known as \"red man syndrome\") is due to direct histamine release and is not generally an allergy, and therefore is not considered an exclusion.\n\n5\\. Treating team deems enrolment in the domain is not in the best interest of the patient 6. Polymicrobial bacteraemia (defined as more than one organism \\[at species level\\] in blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician) reported between collection of the index blood culture and backbone domain eligibility assessment.\n\n7\\. Patient currently being treated with a systemic antibacterial agent that cannot be ceased or substituted for interventions allocated within the platform (unless antibiotic is listed in Table 1 of the DSA, which specifies allowed antibiotics with limited absorption from the gastrointestinal tract or negligible antimicrobial activity against S. aureus)\n\nEARLY ORAL SWITCH DOMAIN\n\nInclusion Criteria:\n\nDay 7 (+\u002F- 2 days):\n\n1. Clearance of SAB by platform Day 2: blood cultures negative for S. aureus from platform Day 2 onwards AND no known subsequent positive blood cultures\n2. Afebrile (\\\u003C37.8°C) for the past 72 hours (at time of judging eligibility)\n3. Primary focus is either line related (either central or peripheral IV cannula) or skin and soft tissue, AND source control achieved (for 'line-related' this means line removed; for 'skin and soft tissue' means site PI considers source control to have been achieved and any abscess more than 2cm diameter has been drained)\n4. No evidence of metastatic foci (on clinical or radiological examination, but radiological imaging is not required to exclude metastatic foci if not clinically indicated)\n\nDay 14 (+\u002F- 2 days):\n\n1. Clearance of SAB by platform Day 5: blood cultures negative for S. aureus from platform Day 5 (+\u002F-1 day) AND no known subsequent positive blood cultures. If the most recent blood culture from Day 2-4 is negative for S. aureus, blood cultures do not need to be repeated on Day 5 to fulfil eligibility criteria (Day 5 blood cultures will be assumed to be negative in this situation)\n2. Afebrile (\\\u003C37.8°C) for the past 72 hours (at time of judging eligibility)\n3. Site Principal Investigator has determined that source control is adequate\n\nExclusion Criteria:\n\nWhen judging eligibility at platform Day 7 (+\u002F- 2 days) and at Day 14 (+\u002F- 2 days), exclusion criteria are:\n\n1. Adherence to oral agents unlikely (as judged by site PI in consultation with the treating team)\n2. Unreliable gastrointestinal absorption (e.g. vomiting, diarrhoea, nil by mouth, anatomical reasons)\n3. There are no appropriate oral antibiotics due to contraindications, drug availability, or antibiotic resistance\n4. Ongoing IV therapy unsuitable e.g. no IV access\n5. Clinician deems not appropriate for early oral switch\n6. Patient no longer willing to participate in domain In the lead-up to judging eligibility, it may be helpful to discuss with the patient the potential for continued IV treatment versus oral switch, to allow hospital discharge planning\n7. Clinical team deems that sufficient duration of antibiotic therapy has already been provided\n\nExclusions when judging eligibility for early oral switch at trial Day 7 (+\u002F- 2 days):\n\n1. Presence of prosthetic cardiac valve, pacemaker or other intracardiac implant\n2. Presence of intravascular clot, graft, or other intravascular prosthetic material Intravascular clot excludes superficial peripheral IV line-related thrombophlebitis. Intravascular prosthetic material excludes coronary artery stents)\n3. Intravascular\u002Fintracardiac infections (e.g. endocarditis, mycotic aneurysm)\n4. Presence of other intracardiac abnormalities felt to put patient at increased risk of endocarditis (e.g., bicuspid aortic valve)\n\nPET\u002FCT DOMAIN\n\nInclusion Criteria:\n\n1. PET\u002FCT participating site\n2. Patient is accessible for PET\u002FCT - a patient is considered accessible if the site team are able to access the participant medical records, arrange for a PET\u002FCT scan for the patient, and discuss this domain with the patient and their treating healthcare providers.\n\nExclusion Criteria:\n\n1. Pregnant - patients of childbearing potential should be assessed for pregnancy status and a pregnancy test performed (if not performed within the past 10 days)\n2. Currently breastfeeding\n3. \\\u003C 18 years of age\n4. Patient has had PET\u002FCT in the past 7 days\n5. Patient needs PET\u002FCT in the next 7 days (in the opinion of the clinical team, at the time of eligibility assessment)\n6. Clinically unstable for PET\u002FCT (as judged by the treating clinical team, taking into account need for organ support (including inotropes) and capacity to lie flat for the PET\u002FCT)\n7. Contraindication to PET\u002FCT (e.g., claustrophobia, persistently elevated blood sugar levels \\[\\>12.5mmol\u002FL\\] that cannot be corrected).\n8. Patient no longer willing to participate in the domain - in the days leading up to judging eligibility, it may be helpful to discuss with the patient the potential for PET\u002FCT vs no PET\u002FCT to allow imaging planning\n9. Clinician deems participation in this domain is not in the patient's best interests",{"count":89,"type":21},8000,[24],"The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is an International Multi-Centered Randomised Adaptive Platform Clinical Trial to evaluate a range of interventions to reduce mortality for patients with Staphylococcus Aureus bacteraemia (SAB).",[28],[94,95,96,69,97,98],"Methicillin-resistant Staphylococcus aureus (MRSA)","Methicillin-susceptible Staphylococcus aureus (MSSA)","Penicillin-susceptible Staphylococcus aureus (PSSA)","S. aureus","Staph Aureus Bacteremia (SAB)","2026-04-29",{"date":101,"type":43},"2026-05-06",{"date":103,"type":43},"2022-02-16",{"date":105,"type":21},"2028-12-01",{"name":107,"class":50},"University of Melbourne",161,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100566078","phase-4-dabigatran-vs-oral-anti-xa-inhibitors-in-s-aureus-bacteremia-100566078","NCT06650501","Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia","DABI-SNAP","The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:\n\nInclusion Criteria:\n\n* Patient is taking (or will imminently start taking) an oral Xa inhibitor (e.g., apixaban, edoxaban, rivaroxaban) for: stroke prevention in atrial fibrillation, treatment or secondary prevention of deep venous thrombosis or pulmonary embolism, prevention of VTE in patients who have undergone elective total hip or total knee replacement surgery provided there are 30 or more days of planned treatment remaining at the time of enrolment.\n\nExclusion Criteria:\n\n* Active bleeding as determine by the site investigator after discussion with the treating team (patient may remain eligible for up to 120 hours from platform entry if condition is resolved and antithrombotic therapy is resumed)\n* Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days\n* Known pregnancy (with testing available for women with childbearing potential)\n* Known use of dabigatran within last month\n* Allergy to dabigatran\n* Concomitant use of amiodarone, ketoconazole, rifampin, verapamil, clopidogrel, prasugrel, or ticagrelor\n* eGFR \\\u003C 30mL\u002Fminute calculated by Cockcroft-Gault equation using adjusted weight \\[patient may remain eligible for up to 120 hours from platform entry if acute kidney injury is resolved such that antithrombotic therapy can be safely resumed\u002Fprescribed\\]\n* Off label use (e.g., metallic mechanical heart valve, left ventricular thrombus, antiphospholipid antibody syndrome)",{"count":20,"type":21},[24],"This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking oral anticoagulant medications (apixaban, edoxaban, or rivaroxaban) for an approved indication (stroke prevention in atrial fibrillation, prevention or treatment of venous thromboembolism). We will randomize patients to continue their existing medication or change to another medication (dabigatran) which is approved for the original indication.\n\nDabigatran is approved in many countries for the treatment or prevention of venous thromboembolism or preventing stroke in atrial fibrillation. Unlike the other medications listed above, dabigatran seems to have activity against S. aureus in the test tube, in animal models, and in a smaller randomized controlled trial. We wish to determine if changing to dabigatran will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it.\n\nThis study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119).\n\nIf positive, this study will support a second RCT in people who do not currently have an indication for anticoagulation.",[31,27,28,120,29,30],"Staphylococcus Aureus Bloodstream Infection",[33,36,122,123,124,125,126],"S. aureus endocarditis","Dabigatran","Edoxaban","Rivaroxaban","Apixaban","2026-03-17",{"date":129,"type":43},"2026-03-20",{"date":131,"type":43},"2026-01-15",{"date":133,"type":21},"2030-01",{"name":135,"class":50},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",1,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100621920","phase-4-combination-antibiotic-therapy-for-staphylococcus-aureus-bacteremia-100621920","NCT07376889","Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia","COMBAT-SAB: Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia","COMBAT-SAB","Inclusion Criteria:\n\n* Age ≥18 years\n* Alive and admitted to an Intermountain Health (IH) hospital acute care unit at enrollment\n* Initial positive blood culture with either methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-susceptible Staphylococcus aureus (MSSA), collected:\n\n  1. on or during the index admission to an IH hospital, or\n  2. in an ambulatory setting (laboratory, clinic or emergency department) within 48 hours of the index admission, or\n  3. at a non-IH network hospital within 24 hours of subsequent transfer to an IH hospital\n\n     Exclusion Criteria:\n* Patient requests that patient health data not be included in the analysis",{"count":146,"type":21},2096,[24],"The purpose of this study is to see if, in selected patients with a serious bacterial infection of the bloodstream, treating the bacterial infection with a combination of antibiotics is more effective than treating the infection with a single antibiotic. Participants must have blood cultures which are positive for a certain type of bacteria.",[28],[151],"Combination antibiotic therapy","NOT_YET_RECRUITING","2026-01-26",{"date":155,"type":43},"2026-01-29",{"date":157,"type":21},"2026-02-01",{"date":159,"type":21},"2029-01",{"name":161,"class":50},"Intermountain Health Care, Inc.",13,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":80},"100529030","evaluating-simplified-layered-consent-for-clinical-trials-100529030","NCT06168474","Evaluating Simplified Layered Consent for Clinical Trials","Evaluating the Impact of a SIMPlified LaYered Consent Process on Recruitment of Potential Participants to the Staphylococcus Aureus Network Adaptive Platform Trial: a Pragmatic Nested Randomized Clinical Trial","SIMPLY-SNAP","Inclusion Criteria:\n\n* All inclusion criteria from the larger SNAP trial:\n\n  1. S. aureus complex grown from ≥1 blood culture\n  2. Admitted to a participating hospital at the time of eligibility assessment\n* Specific additional inclusion criteria for SIMPLY-SNAP:\n\n  1. Admitted to participating hospital of SIMPLY-SNAP\n  2. Self-reported proficiency in English or French adequate to be able to participate in consent process carried out solely in English or French (as the supplementary consent materials required in the simplified consent process are currently only available in these two languages)\n\nExclusion Criteria:\n\n* All exclusion criteria from larger SNAP trial:\n\n  1. Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture\n  2. Polymicrobial bacteremia, defined as more than one organism in the index blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician\n  3. Patient currently being treated with a systemic antibacterial agent that cannot be ceased\n  4. Known previous participation in SNAP\n  5. Known positive blood culture for S. aureus between 72 hours and 180 days prior to the time of eligibility assessment\n  6. Treating team deems enrolment in the study is not in the best interest of the patient\n  7. Treating team believes that death is imminent and inevitable\n  8. Patient is for end-of-life care and antibiotic treatment is considered inappropriate\n  9. Patient \\\u003C18 years of age and paediatric recruitment not approved at recruiting site\n* Specific additional exclusion criteria for SIMPLY-SNAP: None",{"count":172,"type":21},346,[174],"NA","The goal of this clinical trial (the SIMPLY-SNAP trial) is to compare a simplified layered consent form to a full-length consent form for use during the informed consent process for a larger clinical trial of treatment of Staphylococcus aureus bloodstream infection (the SNAP trial).\n\nThe main questions it aims to answer are:\n\n* Does use of a simplified layered consent form lead to an increased recruitment rate to the SNAP trial?\n* Does use of a simplified layer consent form lead to increased participant understanding of the SNAP trial and increased participant satisfaction with the informed consent process?\n\nParticipants will be randomized to either the full-length informed consent form or the simplified layered consent form containing links to optional supplementary information or videos. Research staff will use the assigned form to explain the SNAP trial to participants. After consent, participants will be evaluated on their understanding of the SNAP trial and satisfaction with the consent process using a questionnaire.",[28],[178,179,180,181,182],"informed consent","research ethics","clinical trials","Staphylococcus aureus bacteremia","equity, diversity and inclusion","2025-05-12",{"date":185,"type":43},"2025-05-15",{"date":187,"type":43},"2023-11-28",{"date":189,"type":21},"2026-06",{"name":191,"class":50},"Sunnybrook Health Sciences Centre",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":201,"phases":4,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":136},"100560227","identification-and-validation-of-clinical-phenotypes-in-staphylococcus-aureus-bacteremia-and-their-association-with-mortality-and-development-of-complicated-bacteremia-100560227","NCT06574399","Identification and Validation of Clinical Phenotypes in Staphylococcus Aureus Bacteremia and Their Association With Mortality and Development of Complicated Bacteremia","FEN-AUREUS","FOR STANDARD STUDY:\n\nInclusion Criteria:\n\n* Adults and children with clinically significant Staphylococcus aureus bacteremia (at least two classic systemic inflammatory response criteria: fever, tachycardia, tachypnea, lowered awareness, low blood pressure, leucocytosis\u002Fleucopenia, organ failure)\n\nExclusion Criteria:\n\n* Patients with non-clinically significant bacteremia.\n* Death within 48 hours after detection of bacteremia for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases.\n* Patients under palliative sedation at the time of bacteremia report.\n* Polymicrobial bacteremia.\n\nFOR EXTENDED STUDY:\n\nInclusion Criteria:\n\n* Adults with clinically significant Staphylococcus aureus bacteremia included in the Standard Study\n* Selected at random as one of the model phenotypes until completing recruitment (only HUVM and HUVV)\n\nExclusion Criteria:\n\n* Patients with non-clinically significant bacteremia.\n* Death within 48 hours after detection of bacteremia for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases.\n* Patients under palliative sedation at the time of bacteremia report.\n* Polymicrobial bacteremia.",{"count":200,"type":21},1000,"OBSERVATIONAL","The goal of this observational study is to determine retrospectively whether different patient clinical phenotypes (adults and children) develop Staphylococcus aureus bacteremia.The main questions it aims to answer qre:\n\n1. Evaluate its reproducibility and correlation with mortality\n2. Derive and validate a simplified probabilistic model for phenotype assignment\n3. External validation of the simplified probabilistic phenotype assignment model found and its association with mortality and development of complicated bacteremia in a prospective cohort\n4. Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes.",[28],"2024-08-26",{"date":206,"type":43},"2024-08-27",{"date":208,"type":43},"2023-05-01",{"date":210,"type":21},"2025-03-31",{"name":212,"class":50},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":239},"100541973","phase-3-early-intravenous-to-oral-antibiotic-switch-in-uncomplicated-staphylococcus-aureus-bacteraemia-100541973","NCT06336824","Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia","Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia: The EVOS Randomized Controlled Trial","EVOS","Inclusion Criteria:\n\n1. Blood culture positive for Staphylococcus aureus (S. aureus).\n2. Received 3 to 7 days of definitive IV antimicrobial therapy, defined as:\n\n   * Cloxacillin or cefazolin for methicillin-sensitive staphylococcus aureus (MSSA); Vancomycin or ceftaroline for methicillin-resistant staphylococcus aureus (MRSA).\n   * Proven in-vitro susceptibility and adequate dosing given (as determined by the principal investigator).\n3. Achieved clearance of bacteraemia, defined as at least one documented latest negative follow-up blood culture obtained within 72 hours after the initiation of definitive IV antimicrobial therapy.\n4. Achieved defervescence, defined as sustained body temperature ≤37.5°C within 48 hours before randomization.\n5. Able to provide written informed consent to participate trial.\n\nExclusion Criteria:\n\n1. Evidence of metastatic infection of S. aureus: for example, infective endocarditis, intraabdominal abscess, lung empyema, and osteomyelitis. Radiological investigations such as chest X-ray, ultrasound, echocardiogram, and CT scan are not mandatory prior to enrolment, but should be done at the discretion of the treating physician if clinically indicated.\n2. Septic shock, defined as hypotension requiring vasopressors to maintain MAP ≥65 mmHg despite adequate volume resuscitation.\n3. Received more than 5 days of non-study antibiotics as empirical therapy prior to enrolment.\n4. Polymicrobial bloodstream infection, defined as isolation of pathogens other than S. aureus from a blood culture obtained prior to randomization. Common skin contaminants such as coagulase-negative staphylococci, Bacillus spp., and diphtheroid will not be considered to represent polymicrobial infection.\n5. Known history of S. aureus infection within the past 3 months.\n6. Inability to tolerate oral therapy or poor absorption of oral medications, or not suitable for ongoing IV therapy (for example, difficult intravenous access)\n7. No options of oral antibiotic available for patient due to:\n\n   * In vitro resistance of S. aureus to all oral study drugs.\n   * Known contraindications to receive the active oral study drugs. For example, hypersensitivity reaction to trimethoprim-sulfamethoxazole, thrombocytopenia secondary to linezolid etc.\n   * Non-availability of oral study drugs at the study sites.\n8. Patient is concomitantly receiving oral antibiotics which are active against S. aureus. For example, trimethoprim-sulfamethoxazole for Pneumocystis jirovecii pneumonia prophylaxis.\n9. Presence of a non-removable foreign body such as prosthetic heart valve, vascular graft, pacemaker, automated implantable cardioverter-defibrillator, ventriculoperitoneal shunt, prosthetic joint, and fracture fixation implant\n10. Failure or inability to remove intravascular catheter that is present when first positive blood culture was drawn.\n11. Known comorbidity that increased the risk of complicated infections:\n\n    * End-stage renal disease\n    * Severe liver disease (Child-Pugh class C)\n    * Severe immunodeficiency:\n\n      * HIV-positive patients with CD4\\\u003C200 cells\u002FuL or AIDS\n      * primary immunodeficiency disorders\n      * high-dose steroid therapy (\\>1 mg\u002Fkg prednisone or equivalent doses given for \\> 4 weeks or planned during intervention)\n      * immunosuppressive therapy\n      * neutropenia (\\\u003C500 neutrophils\u002Fμl) at randomization or neutropenia expected during intervention phase due to immunosuppressive treatment\n      * solid organ or hematopoietic stem cell transplantation within the past 6 months or planned during treatment period\n\n13.Short life expectancy \\\u003C 3 months\n\n14.Pregnancy (for women of childbearing potential)",{"count":222,"type":21},290,[224],"PHASE3","The Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus aureus Bacteraemia (EVOS) study is a multicentre, randomized, open-label, parallel group, phase 3, non-inferiority trial of early intravenous to oral antibiotic switch in comparison with standard intravenous antibiotic regime among patients with uncomplicated Staphylococcus aureus bacteraemia (SAB). The study is based on the hypothesis that an early switch from IV to oral antimicrobial therapy is non-inferior and safe compared to conventional minimum 14-day course of IV therapy in patients with low-risk uncomplicated SAB.",[28],[228,229,69],"bacteremia","oral antibiotics","2024-07-02",{"date":232,"type":43},"2024-07-05",{"date":234,"type":43},"2024-06-28",{"date":236,"type":21},"2025-06",{"name":238,"class":50},"Clinical Research Centre, Malaysia",12,{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":258,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":4},"100467006","18-fluorodeoxyglucose-positron-emission-tomographycomputed-tomography-in-s-aureus-bacteraemia-100467006","NCT05361135","18-fluorodeoxyglucose Positron Emission Tomography\u002FComputed Tomography in S. Aureus Bacteraemia","18-fluorodeoxyglucose Positron Emission Tomography\u002FComputed Tomography in Staphylococcus Aureus Bacteraemia (Bacteremia\u002FBloodstream Infection); an International, Multicentre, Randomised Control Trial","PET-SAB","Inclusion Criteria:\n\n* Adult (≥18 years of age)\n* Staphylococcus aureus complex grown from ≥1 blood culture\n* Symptoms of S. aureus bloodstream infection\n* Admitted to a participating hospital at the time of eligibility assessment . Agrees to PET\u002FCT\n\nExclusion Criteria:\n\n* Contraindication to PET\u002FCT (including pregnancy\u002Fbreast-feeding)\n* PET\u002FCT in the last 7 days or already planned to occur in the next 7 days\n* Treating team deems enrolment in the study is not in the best interest of the patient\n* Treating team believes that death is imminent and inevitable\n* Patient is for end-of-life care and PET\u002FCT is considered not appropriate",{"count":249,"type":21},820,[174],"Having bacteria in the blood can be very dangerous. This is called bacteraemia (or bacteremia) or bloodstream infection. It can lead to problems across the whole body, which is what happens in sepsis. Bacteria called Staphylococcus aureus (S. aureus) cause one kind of bacteraemia. Up to a third of people with this condition die within three months, even with antibiotics. One reason for such severe problems is that the bacteria can spread almost anywhere in the body, and hide in places where they are very hard to find. When people with S. aureus bacteraemia come into hospital and have had antibiotics, doctors sometimes cannot tell if they still have an infection source (called a 'focus') hiding in their body. The focus can be like an abscess and may need removing or the pus draining out. A focus might be obvious, if there is pain or swelling, or it might be hidden and deep. If these 'foci' can be found, then doctors can treat them and this helps to cure patients.\n\nTo improve survival for patients with these life-threatening infections, it is vital that doctors find the focus of S. aureus bacteraemia as quickly as possible. However, the research team do not know the best way to do this. Most patients with S. aureus bacteraemia have a chest X-ray and a scan of the heart valves. Patients may go to the scanning department lots of times while doctors try to work out where these foci are. This is uncomfortable and takes a lot of time. In about 1 in 5 cases the doctors still cannot find the focus. This is very worrying for patients, their relatives and doctors.\n\nThis study has been designed by researchers, doctors and patient advocates. It aims to work out if fewer patients may die when a specific type of scan called a 'PET\u002FCT' is done quickly, because it finds more foci. To do this the team plan to do a clinical trial in patients with S. aureus bacteraemia. Half of the patients will receive the usual tests that patients currently get and the other half will receive an extra scan as soon as possible. The patients will be chosen randomly (like the flip of a coin) to go into one of the 2 groups. A year into the trial, an independent committee will check the results to make sure the extra scan is finding more foci. If this is the case, the trial will carry on. At the end of the study, we will share the results globally. The findings are expected to change the way this dangerous condition is managed, so patients do better.",[28,27,253,254,255,256,257],"Sepsis Bacterial","Bloodstream Infection","Staph Sepsis","Staphylococcus Aureus Infection","Sepsis",[259,28,27,257,253,255,256,254,260,261,262,263,264,265,266],"Staphylococcus","Staphylococcus Aureus Bacteraemia","PET","PET\u002FCT","PET-CT","Positron Emission Tomography","Positron Emission Tomography\u002FComputed Tomography","Diagnostic Imaging","2023-05-10",{"date":269,"type":43},"2023-05-15",{"date":271,"type":21},"2023-09",{"date":273,"type":21},"2026-07",{"name":275,"class":50},"University College, London"]