[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560257":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":146,"collaborators":25,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":150,"sex":155,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":25,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":25,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Murdoch Childrens Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control: standard dosing","ACTIVE_COMPARATOR","Enrolled participant will receive standard dosing of IV Ganciclovir dependent on renal function:\n\n* CrCl \\>\u002F= 70mL\u002Fmin: 5 mg\u002Fkg IV 12 hourly\n* CrCl \\>\u002F= 50-69: 2.5 mg\u002Fkg\u002F IV 12 hourly\n* CrCl \\>\u002F= 25-49: 2.5 mg\u002Fkg IV 24 hourly",[13],"Drug: Standard dosing of IV ganciclovir",{"label":15,"type":10,"description":16,"interventionNames":17},"Intervention: individualised dosing using a web app","Enrolled participant will receive a personalised dosing of IV Ganciclovir calculated using an individualised IV ganciclovir dosing app, that considers the patient's weight, creatinine level, and at a target drug exposure (AUC24 between 40-100 mg.h\u002FL), allowing for tailored dosing based on individual pharmacokinetic parameters.",[18],"Drug: Personalised dosing of IV ganciclovir",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Standard dosing of IV ganciclovir","IV ganciclovir at standard dosing",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Personalised dosing of IV ganciclovir","IV ganciclovir at a personalised dosing calculated using a ganciclovir dosing web app",[15],[31],{"name":32,"affiliation":5,"role":33},"Amanda Gwee","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Alice Lei","CONTACT","+61 0433 903 448","alice.lei2@rch.org.au",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Sharelle Joseland","+61 0410052823","sharelle.joseland2@rch.org.au",[45,63,73,87,103,113,127],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Sydney Children's Hospital","RECRUITING","Sydney","New South Wales","2031","Australia","AU",{"type":54,"coordinates":55},"Point",[56,57],151.20732,-33.86785,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":25,"phoneExt":25,"email":62},"Brendan McMullan","brendan.mcmullan@health.nsw.gov.au",{"facility":64,"status":47,"city":48,"state":49,"zip":65,"country":51,"countryCode":52,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"The Children's Hospital at Westmead","2145",{"type":54,"coordinates":67},[56,57],{"lat":57,"lon":56},[70],{"name":71,"role":37,"phone":25,"phoneExt":25,"email":72},"Tony Lai","tony.lai@health.nsw.gov.au",{"facility":74,"status":47,"city":75,"state":76,"zip":77,"country":51,"countryCode":52,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Queensland Children's Hospital","Brisbane","Queensland","4101",{"type":54,"coordinates":79},[80,81],153.02809,-27.46794,{"lat":81,"lon":80},[84],{"name":85,"role":37,"phone":25,"phoneExt":25,"email":86},"Adam Irwin","a.irwin@uq.edu.au",{"facility":88,"status":47,"city":89,"state":90,"zip":91,"country":51,"countryCode":52,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"The Royal Children's Hospital","Melbourne","Victoria","3052",{"type":54,"coordinates":93},[94,95],144.96332,-37.814,{"lat":95,"lon":94},[98,101],{"name":32,"role":37,"phone":99,"phoneExt":25,"email":100},"03 9345 5522","amanda.gwee@rch.org.au",{"name":102,"role":33,"phone":25,"phoneExt":25,"email":25},"Amanda Gwee, MBBS",{"facility":104,"status":47,"city":89,"state":90,"zip":105,"country":51,"countryCode":52,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"Monash Children's Hospital","3168",{"type":54,"coordinates":107},[94,95],{"lat":95,"lon":94},[110],{"name":111,"role":37,"phone":25,"phoneExt":25,"email":112},"Jeremy Carr","jeremy.carr@monashhealth.org",{"facility":114,"status":47,"city":115,"state":116,"zip":117,"country":51,"countryCode":52,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Perth Children's Hospital","Perth","Western Australia","6009",{"type":54,"coordinates":119},[120,121],115.8614,-31.95224,{"lat":121,"lon":120},[124],{"name":125,"role":37,"phone":25,"phoneExt":25,"email":126},"Daniel Yeoh","Daniel.Yeoh@health.wa.gov.au",{"facility":128,"status":47,"city":129,"state":130,"zip":131,"country":132,"countryCode":133,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Starship Children's Hospital","Auckland","North Island","1023","New Zealand","NZ",{"type":54,"coordinates":135},[136,137],174.76349,-36.84853,{"lat":137,"lon":136},[140,143],{"name":141,"role":37,"phone":25,"phoneExt":25,"email":142},"Lesley Voss","lesleyv@adhb.govt.nz",{"name":144,"role":37,"phone":25,"phoneExt":25,"email":145},"Emma Best","ebest@adhb.govt.nz",{"type":147,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100560257","phase-2-individualised-dose-optimisation-of-ganciclovir-in-immunocompromised-children-trial-id-magic-100560257",false,"NCT06574789","Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)","ID-MAGIC","Inclusion Criteria:\n\n1. Immunocompromised patients including transplant recipients (haematopoietic stem cell transplant (HSCT), solid organ transplant (SOT)), those receiving chemotherapy or other immunosuppression or those with a known\u002Fsuspected inborn error of immunity (determined by an immunologist); and\n2. Detectable clinically significant CMV viraemia and treating clinician determines that antiviral therapy is indicated.\n3. Willing to partake in the trial\n4. Willing\u002Fable to attend all follow up visits and capable of completing all trial assessments.\n5. Legally acceptable parent\u002Fguardian capable of providing consent on the participant's behalf.\n6. Treating clinician agreeable to child being enrolled in the trial.\n\nExclusion Criteria:\n\n1. Current or prior CMV infection with documented genotypic resistance to GCV (UL97 and\u002For UL54); or\n2. Severe renal impairment (defined as estimated glomerular filtration rate (eGFR) \\\u003C25mL\u002Fmin); or\n3. Congenital CMV infection; or\n4. Life expectancy of less than 7 days as determined by the treating physician; or\n5. History of allergy, or adverse reaction to GCV, aciclovir or any component of the formulation; or\n6. Treating clinician determines that combination antiviral therapy is indicated for CMV infection; or\n7. Has received \\>3 days of IV GCV or foscarnet or oral valganciclovir for the treatment of CMV infection prior to enrolment; or\n8. Prior enrolment in the trial; or\n9. Current recipient of another investigational product used for the treatment of CMV infection, as part of a clinical trial.","ALL","1 Month","18 Years",{"count":159,"type":160},232,"ESTIMATED","INTERVENTIONAL",[163],"PHASE2","This study is being conducted at seven major children's hospitals in Australia and New Zealand to test a new approach for treating a virus, called cytomegalovirus in children with weakened immune systems. The researchers want to find out if using a web app to customise the dose of a medication called ganciclovir is better at clearing the virus over a six-week period compared to the standard method of giving the medication.",[166],"Cytomegalovirus Viraemia","2026-04-02",{"date":169,"type":170},"2026-04-08","ACTUAL",{"date":172,"type":170},"2024-10-29",{"date":174,"type":160},"2028-12",{"name":5,"class":6},7]