[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"staphylococcus-aureus-bloodstream-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:staphylococcus-aureus-bloodstream-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100637565","phase-1-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-azd7760-in-healthy-japanese-adults-100637565",false,"NCT07612813","A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults","A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants","Inclusion Criteria:\n\n* Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg\u002Fm2 (inclusive) at screening.\n* Healthy Japanese participants with no clinically significant concomitant diseases or medications.\n\nExclusion Criteria:\n\n* Known hypersensitivity to any component of the study intervention.\n* Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.\n* Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.\n* AST or ALT above 1.5 × ULN at screening.\n* Estimated glomerular filtration rate \\\u003C 90 mL\u002Fmin\u002F1.73 m2.\n* Hemoglobin or platelet count below the lower limit of normal at screening.\n* White blood cell counts outside normal reference ranges.\n* History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.\n* Any clinically significant abnormalities on 12-lead ECG at screening,\n* Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.\n* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.\n* Any condition that has the potential to increase clearance of the study intervention.\n* Blood donation or collection as follows:\n\n  1. 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.\n  2. 200 mL whole blood donation within 4 weeks prior to study drug administration.\n  3. Apheresis donation within 2 weeks prior to study drug administration.\n* Absence of suitable veins for blood sampling and administration of study intervention.\n* Any other condition that would compromise the safety of the participants.\n* Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.\n* Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.",[28],"Staphylococcus Aureus Bloodstream Infection","NOT_YET_RECRUITING","2026-05-21",{"date":32,"type":33},"2026-05-29","ACTUAL",{"date":35,"type":22},"2026-06-24",{"date":37,"type":22},"2027-09-24",{"name":39,"class":40},"AstraZeneca","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":41},"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":50,"type":22},300,[52],"PHASE4","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.",[55,56,57,28,58,59],"Staphylococcus Aureus Endocarditis","Staphylococcus Aureus Septicemia","Staphylococcus Aureus Bacteremia","S. Aureus Bacteremia","S. Aureus Bloodstream Infection",[61,62,63,64,65,66,67],"S. aureus bacteremia","S. aureus bloodstream infection","S. aureus endocarditis","Dabigatran","Edoxaban","Rivaroxaban","Apixaban","RECRUITING","2026-03-17",{"date":71,"type":33},"2026-03-20",{"date":73,"type":33},"2026-01-15",{"date":75,"type":22},"2030-01",{"name":77,"class":78},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":96,"leadSponsor":97,"locationsCount":41},"100566077","phase-4-clopidogrel-vs-aspirin-for-cardiovascular-risk-reduction-in-patients-with-s-aureus-bacteremia-100566077","NCT06650488","Clopidogrel vs. Aspirin for Cardiovascular Risk Reduction in Patients With S. Aureus Bacteremia","Clopido-SNAP 2","The participant must meet all inclusion and exclusion criteria for the SNAP\n\nPlatform (NCT05137119) and also the following inclusion and exclusion criteria:\n\nInclusion Criteria:\n\n* Patient is taking aspirin for secondary prevention of cardiovascular disease (coronary, cerebrovascular, or peripheral vascular disease)\n\nExclusion Criteria:\n\n* Active bleeding (allowing up to 3 days from platform entry to randomize in the event anti-thrombotic therapy is resumed)\n* Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days\n* Pregnancy\n* Known receipt of clopidogrel, prasugrel, or ticagrelor within the last month\n* Allergy to clopidogrel\n* Concomitant receipt of oral Xa inhibitor",{"count":50,"type":22},[52],"This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking aspirin for secondary prevention of cardiovascular events. We will randomize patients to continue their aspirin or change clopidogrel which is also approved for secondary prevention.\n\nUnlike aspirin, clopidogrel may have activity against S. aureus. We wish to determine if changing to clopidogrel 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 Phase 3 RCT in people who do not currently have an indication for clopidogrel.",[55,56,28],[91,62,63,92,93],"S. aureus bactremia","aspirin","clopidogrel",{"date":71,"type":33},{"date":73,"type":33},{"date":75,"type":22},{"name":98,"class":78},"Todd C. Lee MD MPH FIDSA"]