[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628729":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":41,"collaborators":43,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":19,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Tennessee","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cefiderocol","EXPERIMENTAL","Patients receiving cefiderocol",[13],"Drug: Cefiderocol",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Cefiderocol will be prescribed according to indication and estimated renal function as either 2g over 3 hours dosed either every 6 or 8 hours.",[9],null,[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Regional One Health","RECRUITING","Memphis","Tennessee","38103","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-90.04898,35.14953,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"David Hill, Pharm.D., M.S.","CONTACT","901-545-8090","dhill19@uthsc.edu",{"type":42,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[44,47,50],{"name":45,"class":46},"Shionogi Inc.","INDUSTRY",{"name":48,"class":49},"Regional Medical Center, Regional One Health","UNKNOWN",{"name":51,"class":49},"Center for Anti-Infective Research and Development","100628729","phase-4-pharmacokinetic-analysis-of-cefiderocol-in-patients-with-acute-burn-injuries-100628729",false,"NCT07465432","Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries","Inclusion Criteria:\n\n* age ≥ 18 and ≤ 80 years old\n* estimated CLCR (eCLCR) ≥ 60 mL\u002Fmin via Cockcroft-Gault equation\n\nExclusion Criteria:\n\n* KDIGO classification ≥ 1 at day of screening\n* known HIV or HBV infection","ALL","18 Years","80 Years",{"count":62,"type":63},12,"ESTIMATED","INTERVENTIONAL",[66],"PHASE4","Cefiderocol is a powerful, broad spectrum antibiotic approved to treat hospital-acquired or ventilator associated pneumonia and urinary tract infections. Although cefiderocol has labeled dosing recommendations, including augmented renal clearance, patients with burn injury remain an unstudied population at high risk for MDR pathogens. The primary objective of this study is to evaluate the pharmacokinetic principles of cefiderocol in patients after acute burn injury. Findings from this study will determine the dose and interval necessary to maintain therapeutic concentrations of cefiderocol in patients after burn injury for adequate bactericidal activity, prevention of resistance, and treatment outcomes.",[69],"Drug Clearance After Severe Burn Injury",[71,72,73,74,75,76],"burns","cefiderocol","pharmacokinetics","pharmacodynamics","augmented renal clearance","Gram-negative bacterial infections","2026-03-05",{"date":79,"type":80},"2026-03-12","ACTUAL",{"date":82,"type":63},"2026-02-16",{"date":84,"type":63},"2027-02-28",{"name":5,"class":6},1]