[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498466":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":81,"collaborators":83,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":19,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":19,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Murdoch Childrens Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Vancomycin first-dose trough dose adjustment calculation","EXPERIMENTAL","Participants will have individualised model-based intermittent vancomycin dosing using the Vanc App dosing calculator (as used in VANC APP Part 1, see clinicaltrials.gov ID: NCT04044703). A first-dose trough concentration will be measured for each participant and the clinician will then enter that concentration into the web application ('First-dose trough dose adjustment calculator'). A dose adjustment will be generated by the calculator if the predicted steady-state level is outside of target range. If the predicted steady-state level is within target range (10-20mg\u002FL) the calculator will recommend continuing with the same dose. The vancomycin concentration is then measured at steady state to determine if the target concentration has been achieved.",[13],"Other: First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg\u002FL)",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"First-dose trough dose adjustment calculator - using early TDM (first-dose trough) to determine an early dose adjustment if the predicted steady-state trough is outside of target range (10-20mg\u002FL)","CALCULATOR: A 'First-dose trough dose adjustment calculator' was developed based on a population pharmacokinetic model. A participant's post-menstrual age, weight, creatinine, target trough concentration, dose, dosing interval and first-dose trough concentration (taken immediately before the second dose is due) are entered into the calculator. The calculator determines if a dose adjustment is required (based on whether the predicted steady-state trough concentration is \\\u003C10mg\u002FL or \\>20mg\u002FL) and, if required, recommends a new adjusted dose.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Amanda Wilkins, MBBS","Royal Children's Hospital Melbourne, Murdoch Children's Research Institute","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","9345 5522","amanda.wilkins@rch.org.au",{"name":31,"role":27,"phone":28,"phoneExt":19,"email":32},"Amanda Gwee, MBBS","amanda.gwee@rch.org.au",[34,53,62,73],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Royal Children's Hospital Melbourne","RECRUITING","Melbourne","Victoria","3052","Australia","AU",{"type":43,"coordinates":44},"Point",[45,46],144.96332,-37.814,{"lat":46,"lon":45},[49,52],{"name":50,"role":27,"phone":51,"phoneExt":19,"email":29},"Amanda L Wilkins, MBBS","+61393455522",{"name":50,"role":24,"phone":19,"phoneExt":19,"email":19},{"facility":54,"status":55,"city":37,"state":19,"zip":19,"country":40,"countryCode":41,"cosmosGeoPoint":56,"geoPoint":58,"contacts":59},"Monash Newborn","NOT_YET_RECRUITING",{"type":43,"coordinates":57},[45,46],{"lat":46,"lon":45},[60],{"name":61,"role":27,"phone":19,"phoneExt":19,"email":19},"Atul Malhotra",{"facility":63,"status":55,"city":64,"state":19,"zip":19,"country":40,"countryCode":41,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Royal Hospital for Women","Sydney",{"type":43,"coordinates":66},[67,68],151.20732,-33.86785,{"lat":68,"lon":67},[71],{"name":72,"role":27,"phone":19,"phoneExt":19,"email":19},"Srinivas Bolisetty",{"facility":74,"status":36,"city":64,"state":19,"zip":19,"country":40,"countryCode":41,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"The Children's Hospital at Westmead",{"type":43,"coordinates":76},[67,68],{"lat":68,"lon":67},[79],{"name":80,"role":27,"phone":19,"phoneExt":19,"email":19},"Tony Lai",{"type":82,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[84,86,88,90],{"name":85,"class":6},"Royal Children's Hospital",{"name":87,"class":6},"Royal Hospital For Women",{"name":89,"class":6},"Sydney Children's Hospitals Network",{"name":91,"class":6},"Monash Health","100498466","phase-4-improving-therapeutic-drug-monitoring-and-dosing-for-vancomycin-in-young-infants-with-infections-vancapp-part-2-100498466",false,"NCT05770622","Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)","The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 2)","VANCAPP","Inclusion Criteria:\n\n* Infants aged 0 - 90 days old\n* Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)\n\nExclusion Criteria:\n\n* Infants with a corrected gestational age of less than 25 weeks\n* Infants weighing less than 500g.\n* Known allergy to any glycopeptide antibiotic\n* Vancomycin administered within the previous 72 hours\n* Infants receiving any form of extracorporeal life support\n* Renal impairment","ALL","0 Days","90 Days",{"count":104,"type":105},40,"ESTIMATED","INTERVENTIONAL",[108],"PHASE4","A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. If the target concentration is not achieved, the dose needs to be adjusted, resulting in further delays in an infant achieving the concentration required to treat their infection. The purpose of this study is to assess the use of early therapeutic drug monitoring (first-dose trough) and, if needed, early dose adjustment, in achieving target vancomycin concentrations at steady state. A dose adjustment calculator (available through a web application) will be used to determine the need for dose adjustment (based on predicted steady state concentration) and recommend an adjusted dose if required.",[111,112,113],"Sepsis","Infections","Bacteremia","2026-04-15",{"date":116,"type":117},"2026-04-20","ACTUAL",{"date":119,"type":117},"2024-11-10",{"date":121,"type":105},"2027-04",{"name":5,"class":6},4]