[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100120636":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":25,"responsibleParty":225,"collaborators":20,"id":227,"slug":228,"hasResults":229,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":20,"eligibilityCriteria":233,"healthyVolunteers":234,"sex":235,"minAge":236,"maxAge":237,"enrollmentInfo":238,"targetDuration":20,"studyType":241,"phases":242,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":249,"whyStopped":250,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":259},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium).",[13],"Drug: Voriconazole",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Voriconazole","All subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy.\n\nGroup 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (\\\u003C50 kg) will receive 9 mg\u002Fkg IV every 12 hours (q12h) on day 1, then 8 mg\u002Fkg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg\u002Fkg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator.\n\nGroup 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing \\\u003C50 kg) will receive 6 mg\u002Fkg IV q12h on day 1, then 4 mg\u002Fkg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[26,39,48,58,68,78,84,90,95,100,112,117,127,132,143,154,164,170,181,186,191,200,205,217,221],{"facility":27,"status":20,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":20},"Childrens Hospital Los Angeles","Los Angeles","California","90027","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-118.24368,34.05223,{"lat":37,"lon":36},{"facility":40,"status":20,"city":41,"state":29,"zip":42,"country":31,"countryCode":32,"cosmosGeoPoint":43,"geoPoint":47,"contacts":20},"Children's Hospital & Research Center Oakland (CHRCO)","Oakland","94609",{"type":34,"coordinates":44},[45,46],-122.2708,37.80437,{"lat":46,"lon":45},{"facility":49,"status":20,"city":50,"state":51,"zip":52,"country":31,"countryCode":32,"cosmosGeoPoint":53,"geoPoint":57,"contacts":20},"Children's Hospital of Pittsburgh of UPMC","Pittsburgh","Pennsylvania","15224",{"type":34,"coordinates":54},[55,56],-79.99589,40.44062,{"lat":56,"lon":55},{"facility":59,"status":20,"city":60,"state":61,"zip":62,"country":31,"countryCode":32,"cosmosGeoPoint":63,"geoPoint":67,"contacts":20},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":34,"coordinates":64},[65,66],-95.36327,29.76328,{"lat":66,"lon":65},{"facility":69,"status":20,"city":70,"state":71,"zip":72,"country":31,"countryCode":32,"cosmosGeoPoint":73,"geoPoint":77,"contacts":20},"Children's Pavilion, Virginia Commonwealth University Health System","Richmond","Virginia","23219",{"type":34,"coordinates":74},[75,76],-77.46026,37.55376,{"lat":76,"lon":75},{"facility":79,"status":20,"city":70,"state":71,"zip":80,"country":31,"countryCode":32,"cosmosGeoPoint":81,"geoPoint":83,"contacts":20},"Virginia Commonwealth University Health System, Hospital Pharmacy","23298-0042",{"type":34,"coordinates":82},[75,76],{"lat":76,"lon":75},{"facility":85,"status":20,"city":70,"state":71,"zip":86,"country":31,"countryCode":32,"cosmosGeoPoint":87,"geoPoint":89,"contacts":20},"Pediatric Hematology and Oncology, Virginia Commonwealth University Health System","23298",{"type":34,"coordinates":88},[75,76],{"lat":76,"lon":75},{"facility":91,"status":20,"city":70,"state":71,"zip":86,"country":31,"countryCode":32,"cosmosGeoPoint":92,"geoPoint":94,"contacts":20},"Virginia Commonwealth University\u002FMCV Clinical Pathology",{"type":34,"coordinates":93},[75,76],{"lat":76,"lon":75},{"facility":96,"status":20,"city":70,"state":71,"zip":86,"country":31,"countryCode":32,"cosmosGeoPoint":97,"geoPoint":99,"contacts":20},"Virginia Commonwealth University",{"type":34,"coordinates":98},[75,76],{"lat":76,"lon":75},{"facility":101,"status":20,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":20},"Alberta Children's Hospital, Pediatric Oncology Office","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":34,"coordinates":108},[109,110],-114.08529,51.05011,{"lat":110,"lon":109},{"facility":113,"status":20,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":114,"geoPoint":116,"contacts":20},"Alberta Children's Hospital",{"type":34,"coordinates":115},[109,110],{"lat":110,"lon":109},{"facility":118,"status":20,"city":119,"state":20,"zip":120,"country":121,"countryCode":20,"cosmosGeoPoint":122,"geoPoint":126,"contacts":20},"Fakultni nemocnice Brno","Brno","625 00","Czechia",{"type":34,"coordinates":123},[124,125],16.60796,49.19522,{"lat":125,"lon":124},{"facility":118,"status":20,"city":119,"state":20,"zip":128,"country":121,"countryCode":20,"cosmosGeoPoint":129,"geoPoint":131,"contacts":20},"62500",{"type":34,"coordinates":130},[124,125],{"lat":125,"lon":124},{"facility":133,"status":20,"city":134,"state":20,"zip":135,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":142,"contacts":20},"UMC St. Radboud","Nijmegen","6500 HB","Netherlands","NL",{"type":34,"coordinates":139},[140,141],5.85278,51.8425,{"lat":141,"lon":140},{"facility":144,"status":20,"city":145,"state":20,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":20},"Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej","Wroclaw","50-345","Poland","PL",{"type":34,"coordinates":150},[151,152],17.03006,51.10286,{"lat":152,"lon":151},{"facility":155,"status":20,"city":156,"state":20,"zip":157,"country":156,"countryCode":158,"cosmosGeoPoint":159,"geoPoint":163,"contacts":20},"National University Hospital","Singapore","119074","SG",{"type":34,"coordinates":160},[161,162],103.85007,1.28967,{"lat":162,"lon":161},{"facility":165,"status":20,"city":156,"state":20,"zip":166,"country":156,"countryCode":158,"cosmosGeoPoint":167,"geoPoint":169,"contacts":20},"KK Women's and Children's Hospital","229899",{"type":34,"coordinates":168},[161,162],{"lat":162,"lon":161},{"facility":171,"status":20,"city":172,"state":20,"zip":173,"country":174,"countryCode":175,"cosmosGeoPoint":176,"geoPoint":180,"contacts":20},"Hospital General Universitari Vall D'Hebron","Barcelona","08035","Spain","ES",{"type":34,"coordinates":177},[178,179],2.15899,41.38879,{"lat":179,"lon":178},{"facility":182,"status":20,"city":172,"state":20,"zip":173,"country":174,"countryCode":175,"cosmosGeoPoint":183,"geoPoint":185,"contacts":20},"Hospital Universitari Vall d'Hebron. Servicio de Farmacia",{"type":34,"coordinates":184},[178,179],{"lat":179,"lon":178},{"facility":187,"status":20,"city":172,"state":20,"zip":173,"country":174,"countryCode":175,"cosmosGeoPoint":188,"geoPoint":190,"contacts":20},"Hospital Universitario Vall d'Hebron",{"type":34,"coordinates":189},[178,179],{"lat":179,"lon":178},{"facility":192,"status":20,"city":193,"state":20,"zip":194,"country":174,"countryCode":175,"cosmosGeoPoint":195,"geoPoint":199,"contacts":20},"HOSPITAL UNIVERSITARIO 12 DE OCTUBRE Servicio de Farmacia","Madrid","28041",{"type":34,"coordinates":196},[197,198],-3.70256,40.4165,{"lat":198,"lon":197},{"facility":201,"status":20,"city":193,"state":20,"zip":194,"country":174,"countryCode":175,"cosmosGeoPoint":202,"geoPoint":204,"contacts":20},"Hospital Universitario 12 de Octubre",{"type":34,"coordinates":203},[197,198],{"lat":198,"lon":197},{"facility":206,"status":20,"city":207,"state":208,"zip":209,"country":210,"countryCode":211,"cosmosGeoPoint":212,"geoPoint":216,"contacts":20},"Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University","Bangkok Noi","Bangkok","10700","Thailand","TH",{"type":34,"coordinates":213},[214,215],100.47798,13.76266,{"lat":215,"lon":214},{"facility":218,"status":20,"city":219,"state":208,"zip":220,"country":210,"countryCode":211,"cosmosGeoPoint":20,"geoPoint":20,"contacts":20},"Department of Pediatrics, Faculty of Medicine, Chulalongkorn University","Patumwan","10330",{"facility":222,"status":20,"city":223,"state":208,"zip":224,"country":210,"countryCode":211,"cosmosGeoPoint":20,"geoPoint":20,"contacts":20},"Department of Pediatrics, Phramongkutklao hospital","Rajathevee","10400",{"type":226,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100120636","phase-3-a-study-to-evaluate-the-safety-of-voriconazole-as-treatment-of-invasive-aspergillosis-fungal-infection-and-other-rare-molds-in-children-100120636",true,"NCT00836875","A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children","A Prospective, Open-label, Non-randomized, Multi-center Study To Investigate The Safety And Tolerability Of Voriconazole As Primary Therapy For Treatment Of Invasive Aspergillosis And Molds Such As Scedosporium Or Fusarium Species In Pediatric Patients.","Inclusion Criteria:\n\n* Immunocompromised with clinically compatible illness.\n* Diagnosis of proven or probable or possible Invasive Aspergillosis (based on a modified version of the revised EORTC\u002FMSG consensus definitions).\n* Diagnosis of infection due to Scedosporium or Fusarium species.\n* Male and female from 2 to 17 years of age.\n* Females with childbearing potential must have negative pregnancy test and be using appropriate contraception.\n\nExclusion Criteria:\n\n* Allergy or hypersensitivity to the azole drugs.\n* Female subjects who are pregnant or lactating.\n* Patients who received more than four days of antifungal drugs to treat the current episode of invasive aspergillosis or rare mold infection.\n* Received within 24 hours prior to enrollment drugs that may cause QT interval prolongation.\n* Significant liver, kidney or heart dysfunction.\n* Not expected to survive for at least 5 days.",false,"ALL","2 Years","17 Years",{"count":239,"type":240},31,"ACTUAL","INTERVENTIONAL",[243],"PHASE3","The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.",[246],"Invasive Aspergillosis",[248],"Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized","TERMINATED","This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.","2017-05-23",{"date":253,"type":240},"2017-06-16",{"date":255,"type":240},"2009-05",{"date":257,"type":240},"2013-05",{"name":5,"class":6},25]