[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555331":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":175,"collaborators":177,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":209,"sex":210,"minAge":211,"maxAge":18,"enrollmentInfo":212,"targetDuration":18,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":224,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},{"fullName":5,"class":6},"The University of Queensland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Precision Care","EXPERIMENTAL","Voriconazole dosing will be initiated using current standard care dosing. Samples for TDM and genotype testing will be collected. Based on the results of these tests on Day 5, 8, 14, and up to day 30 ( ± 1 day) patients will be evaluated for dose adjustment using dosing software that includes patient data including TDM and genotype data.",[13],"Other: genotype-directed dosing with dosing software based on therapeutic drug monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","NO_INTERVENTION","Current standard of care at trial-site institutions uses weight-based (mg\u002Fkg) initial dosing of voriconazole, with dose adjustment based on standard therapeutic drug monitoring (TDM) results of measured voriconazole concentrations and based on clinical judgement.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"genotype-directed dosing with dosing software based on therapeutic drug monitoring","Genotype-directed dosing with dosing software based on therapeutic drug monitoring",[9],[25],"genotype directed with dosing software",[27],{"name":28,"affiliation":5,"role":29},"Jason A Roberts, PhD","PRINCIPAL_INVESTIGATOR",[31,36],{"name":28,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","+61 7 3346 5032","65032","j.roberts2@uq.edu.au",{"name":37,"role":32,"phone":38,"phoneExt":18,"email":39},"Luminita Vlad","61 7 3346 5045","l.vlad@uq.edu.au",[41,64,84,101,120,136,154],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Fred Hutchinson Cancer Centre","RECRUITING","Seattle","Washington","908109-1024","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-122.33207,47.60621,{"lat":53,"lon":52},[56,60],{"name":57,"role":32,"phone":58,"phoneExt":18,"email":59},"Ashleigh Miller","206-667-1994","amiller3@fredhutch.org",{"name":61,"role":32,"phone":62,"phoneExt":18,"email":63},"Catherine Professor Liu, MD","206-667-2729","catherine.liu@fredhutch.org",{"facility":65,"status":43,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Sydney Children's Hospital Network","Sydney","New South Wales","21452031","Australia","AU",{"type":50,"coordinates":72},[73,74],151.20732,-33.86785,{"lat":74,"lon":73},[77,81],{"name":78,"role":32,"phone":79,"phoneExt":18,"email":80},"Tony Lai","+61 2 9845 2700","tony.lai@health.nsw.gov.au",{"name":82,"role":32,"phone":18,"phoneExt":18,"email":83},"Shirley Wong","shirley.wong@health.nsw.gov.au",{"facility":85,"status":43,"city":66,"state":67,"zip":86,"country":69,"countryCode":70,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Westmead Hospital","2145",{"type":50,"coordinates":88},[73,74],{"lat":74,"lon":73},[91,95,98],{"name":92,"role":32,"phone":93,"phoneExt":18,"email":94},"Johannes Alffenaar","+61 2 8627 0019","johannes.alffenaar@sydney.edu.au",{"name":96,"role":32,"phone":18,"phoneExt":18,"email":97},"Catherine Linh","catherine.linh@health.nsw.gov.au",{"name":99,"role":100,"phone":18,"phoneExt":18,"email":18},"Johannes Alffernaar, PhD, PharmD, Clinical Pharmaco","SUB_INVESTIGATOR",{"facility":102,"status":43,"city":103,"state":104,"zip":105,"country":69,"countryCode":70,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Royal Brisbane & Women's Hospital","Brisbane","Queensland","4029",{"type":50,"coordinates":107},[108,109],153.02809,-27.46794,{"lat":109,"lon":108},[112,116],{"name":113,"role":32,"phone":114,"phoneExt":18,"email":115},"Midori Nakagaki, PhD","+61 7 3647 0185","midori.nakagaki@health.qld.gov.au",{"name":117,"role":32,"phone":118,"phoneExt":18,"email":119},"Amy Legg","+61 7 3647 0802","amy.legg@health.qld.gov.au",{"facility":121,"status":43,"city":122,"state":104,"zip":105,"country":69,"countryCode":70,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Children's Hospital Queensland","South Brisbane",{"type":50,"coordinates":124},[125,126],153.02049,-27.48034,{"lat":126,"lon":125},[129,133],{"name":130,"role":32,"phone":131,"phoneExt":18,"email":132},"Adam D Irwin, MBBS, PhD","07 3346 5075","a.irwin@uq.edu.au",{"name":134,"role":32,"phone":18,"phoneExt":18,"email":135},"Rachael Lawson, PhD","rachael.lawson@health.qld.gov.au",{"facility":137,"status":43,"city":138,"state":139,"zip":140,"country":69,"countryCode":70,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":50,"coordinates":142},[143,144],138.59863,-34.92866,{"lat":144,"lon":143},[147,151],{"name":148,"role":32,"phone":149,"phoneExt":18,"email":150},"Philip R Selby","08 7074 0000","philip.selby@sa.gov.au",{"name":152,"role":32,"phone":18,"phoneExt":18,"email":153},"Jane Rose","Jane.rose@sa.gov.au",{"facility":155,"status":43,"city":156,"state":157,"zip":158,"country":69,"countryCode":70,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Peter MacCallum Cancer Centre","Melbourne","Victoria","3053",{"type":50,"coordinates":160},[161,162],144.96332,-37.814,{"lat":162,"lon":161},[165,169,173],{"name":166,"role":32,"phone":167,"phoneExt":18,"email":168},"Monica Slavin, MBBS, FRACP, MD, FAAHMS, FECMM","+61 3 8559 5000","monica.slavin@petermac.org",{"name":170,"role":32,"phone":171,"phoneExt":18,"email":172},"Rachel Wolstencroft","+61 3 8559 7973","infectiousdiseases.clinicaltrials@petermac.org",{"name":174,"role":100,"phone":18,"phoneExt":18,"email":18},"Monica Slavin, MBBS, PHD",{"type":176,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[178,181,183,185,187,189,191,193,194,196,199],{"name":179,"class":180},"Metro North Hospital and Health Service","UNKNOWN",{"name":182,"class":6},"Fred Hutchinson Cancer Research Center\u002FUniversity of Washington Cancer Consortium",{"name":184,"class":6},"University of Sydney",{"name":186,"class":6},"Western Sydney Local Health District",{"name":188,"class":6},"Sydney Children's Hospitals Network",{"name":190,"class":6},"Peter MacCallum Cancer Centre, Australia",{"name":192,"class":6},"University of Melbourne",{"name":137,"class":6},{"name":195,"class":180},"Pathology Queensland",{"name":197,"class":198},"Royal Brisbane and Women's Hospital","OTHER_GOV",{"name":200,"class":6},"Lady Cilento Children's Hospital, Brisbane","100555331","phase-2-pharmacogenomics-for-better-treatment-of-fungal-infections-clinical-trial-100555331",false,"NCT06510699","Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial","Randomized Clinical Trial to Evaluate the Use of Genotype-based Dosing of Voriconazole","PRAGMATIC","Inclusion Criteria:\n\n* Age ≥ 2 years.\n* Written informed consent obtained.\n* Decision to prescribe voriconazole.\n* Admitted to a trial site, or sufficient outpatient follow-up appointments are feasible\n\nExclusion Criteria:\n\n* Post-allogeneic haematopoietic stem cell transplant (HCT) patient, without access to pre HCT DNA\n* Death is likely imminent within 7 days.\n* Previously randomised to this trial",true,"ALL","2 Years",{"count":213,"type":214},104,"ESTIMATED","INTERVENTIONAL",[217],"PHASE2","This project aims to address invasive fungal infections in patients, by precision dosing of voriconazole based on CYP2C19 genotype testing with Bayesian dose-forecasting dosing software to develop patient-centric and maximally effective dosing regimens. This study investigates if voriconazole increases the proportion of patients achieving therapeutic exposure at day 8 of dosing compared with standard care; and will assess factors that influence the implementation of genotype testing and dosing software in the healthcare system, including fidelity, feasibility, acceptability and cost-effectiveness. It will recruit at least 104 kids and adults in a parallel-group randomised clinical trial. A hybrid feasibility sub-study will assess the scalability of genotype-directed dosing to ensure sustainable integration of the interventions into the clinical workflow. A health economic sub-study will evaluate the costs, health outcomes and cost-effectiveness of genotype-directed testing compared to standard care.",[220,221,222,223],"Fungal Infection","Haematological Malignancy","Blood Cancer","Infectious Disease",[225,226,227,228,229],"infection","cancer","pharmacogenomic","genotype-based dosing","CYP2C19","2026-04-13",{"date":232,"type":233},"2026-04-16","ACTUAL",{"date":235,"type":233},"2025-04-14",{"date":237,"type":214},"2027-03-26",{"name":5,"class":6},7]