[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100216571":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":56,"collaborators":29,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":29,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":29,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":37,"whyStopped":29,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Vancomycin","All included patients receive vancomycin for medical reasons. Decision for start of therapy is made by the treating physician.",[12],"Drug: Vancomycin",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DRUG","vancomycin administration based on decision of treating physician",[9],[19],"Vancomycine Actavis",[21],{"name":22,"affiliation":23,"role":24},"Anne Smits, MD","UZ Leuven","PRINCIPAL_INVESTIGATOR",[26,31],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","003216341564",null,"anne.smits@uzleuven.be",{"name":32,"role":27,"phone":33,"phoneExt":29,"email":34},"Karel Allegaert, MD, PhD","003216343210","karel.allegaert@uzleuven.be",[36],{"facility":23,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":44,"coordinates":45},"Point",[46,47],4.70093,50.87959,{"lat":47,"lon":46},[50,51,53,55],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},{"name":52,"role":27,"phone":33,"phoneExt":29,"email":34},"Karel Allegaert, MD,PhD",{"name":32,"role":54,"phone":29,"phoneExt":29,"email":29},"SUB_INVESTIGATOR",{"name":22,"role":24,"phone":29,"phoneExt":29,"email":29},{"type":57,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100216571","phase-4-exploring-vancomycin-disposition-in-neonates-100216571",false,"NCT02096536","Exploring Vancomycin Disposition in Neonates","Exploring Vancomycin Disposition in Neonates: Paired Analysis of Vancomycin Concentrations Using Immunoassay and Liquid-chromatography-tandem Mass Spectrometry. Determination of Vancomycin Protein Binding and Its Covariates in Neonates","Inclusion Criteria:\n\n* Neonates, admitted to the Neonatal Intensive Care Unit to whom vancomycin is administered for medical reasons, can be included in the study after informed consent of the parents.\n\nExclusion Criteria:\n\n* No vancomycin therapy\n* No signed informed consent available","ALL","1 Day","23 Months",{"count":69,"type":70},120,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","Vancomycin is already used for decades in neonates. However, there are remaining questions concerning vancomycin disposition in this population. The purpose of this study is first of all to perform a paired analysis of serum vancomycin concentrations using an immunoassay versus a reference liquid chromatography-tandem mass spectrometry method. Secondly, we aim to determine vancomycin protein binding and its covariates in neonates.",[76],"Neonatal Infection",[78,9,79,80],"Neonate","LC\u002FMS-MS","protein binding","2024-07-11",{"date":83,"type":84},"2024-07-12","ACTUAL",{"date":86,"type":29},"2014-04",{"date":88,"type":70},"2025-01",{"name":5,"class":6},1]