[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"linezolid-pharmacokinetics-in-young-infants\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:linezolid-pharmacokinetics-in-young-infants":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100655646","phase-4-oral-antibiotic-pharmacokinetics-in-young-infants-100655646",false,"NCT07815613","Oral Antibiotic Pharmacokinetics in Young Infants","Characterizing Absorption Kinetics of Oral Antibiotics in Young Infants to Enhance Precision Dosing","Inclusion Criteria:\n\n* Hospitalized neonate or young infant ≤90 days postnatal age at screening\n* Weight ≥2 kg\n* Receiving systemic antibiotic therapy\n* Tolerating enteral medication(s) and\u002For enteral feeds\n* Group 1: Receiving oral linezolid as part of routine clinical care.\n* Group 2: Receiving systemic antibiotic therapy but not prescribed linezolid clinically and eligible to receive a single oral study dose.\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to linezolid\n* Renal dysfunction (defined by age-appropriate serum creatinine and\u002For urine output)\n* Hepatic dysfunction (AST or ALT ≥3x age-specific upper limit of normal or clinically significant hepatic failure)\n* Gastrointestinal disorders expected to significantly impair drug absorption (e.g., short bowel syndrome, severe malabsorption)\n* Severe anemia or other condition that precludes study-required blood sampling\n* Extracorporeal support or other devices expected to substantially alter drug pharmacokinetics (e.g., extracorporeal membrane oxygenation \\[ECMO\\]).\n* Therapeutic hypothermia\n* Ongoing clinical instability that, in the opinion of the treating team or principal investigator (PI), would make study participation unsafe (e.g., escalating vasoactive support or rapidly worsening organ dysfunction).","ALL","0 Days","90 Days",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This observational study will characterize the pharmacokinetics of linezolid in young infants. Participants will receive linezolid either as part of routine clinical care or as a single, one-time study dose. Blood samples collected following linezolid administration will be used to measure drug concentrations and describe how linezolid is absorbed, distributed, metabolized, and eliminated in this population. Clinical information, including demographic characteristics, laboratory values, and treatment details, will also be collected. The results will be used to develop pharmacokinetic models to improve linezolid dosing recommendations and support precision dosing in young infants.",[27,28,29,30],"Linezolid Pharmacokinetics in Young Infants","Pharmacokinetic Analysis","Linezolid","Infant and Young Children",[32,33,34,35,36],"linezolid","pharmacokinetics","neonate","infant","oral antibiotic","NOT_YET_RECRUITING","2026-09-08",{"date":40,"type":41},"2026-09-11","ACTUAL",{"date":43,"type":21},"2027-01-01",{"date":45,"type":21},"2030-12-31",{"name":47,"class":48},"University of Colorado, Denver","OTHER"]