[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100139974":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":27,"responsibleParty":154,"collaborators":26,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":26,"eligibilityCriteria":162,"healthyVolunteers":163,"sex":164,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":26,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":178,"whyStopped":179,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Active voriconazole","EXPERIMENTAL","All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.",[13],"Drug: voriconazole",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","voriconazole","Subjects 12 - \\\u003C18 yrs (excluding subjects 12 - 14 yrs weighing \\\u003C50kg): For IC, the loading dose is 6 mg\u002Fkg IV q12h on Day 1, followed by 4 mg\u002Fkg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg\u002Fkg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h.\n\nSubjects 2 - \\\u003C12 yrs, and subjects 12 - 14 weighing \\\u003C50kg: For IC, the loading dose is 9 mg\u002Fkg IV q12h on Day 1, followed by 8 mg\u002Fkg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg\u002Fkg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg\u002Fkg q12h (maximum initial dose of 300 mg).\n\nSubjects will be treated for a minimum of 14 days for invasive candidiasis\u002Fcandidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days.",[9],[21],"Vfend",[23],{"name":24,"affiliation":5,"role":25},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",null,[28,41,50,60,70,75,83,94,100,106,113,125,132,143],{"facility":29,"status":26,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":26},"Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology","Wuhan","Hubei","430030","China","CN",{"type":36,"coordinates":37},"Point",[38,39],114.26667,30.58333,{"lat":39,"lon":38},{"facility":42,"status":26,"city":43,"state":26,"zip":44,"country":33,"countryCode":34,"cosmosGeoPoint":45,"geoPoint":49,"contacts":26},"Beijing Children's Hospital, Capital University of Medical Sciences","Beijing","100045",{"type":36,"coordinates":46},[47,48],116.39723,39.9075,{"lat":48,"lon":47},{"facility":51,"status":26,"city":52,"state":26,"zip":53,"country":54,"countryCode":26,"cosmosGeoPoint":55,"geoPoint":59,"contacts":26},"Fakultni nemocnice Brno - Klinika detske onkologie","Brno","625 00","Czechia",{"type":36,"coordinates":56},[57,58],16.60796,49.19522,{"lat":58,"lon":57},{"facility":61,"status":26,"city":62,"state":26,"zip":63,"country":62,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":26},"Department of Paediatrics and Adolescent Medicine","Hong Kong","0","HK",{"type":36,"coordinates":66},[67,68],114.17469,22.27832,{"lat":68,"lon":67},{"facility":71,"status":26,"city":62,"state":26,"zip":26,"country":62,"countryCode":64,"cosmosGeoPoint":72,"geoPoint":74,"contacts":26},"Queen Mary Hospital",{"type":36,"coordinates":73},[67,68],{"lat":68,"lon":67},{"facility":76,"status":26,"city":77,"state":26,"zip":26,"country":62,"countryCode":64,"cosmosGeoPoint":78,"geoPoint":82,"contacts":26},"The Chinese University of Hong Kong, Prince of Wales Hospital","Shatin, N.T.",{"type":36,"coordinates":79},[80,81],114.18333,22.38333,{"lat":81,"lon":80},{"facility":84,"status":26,"city":85,"state":26,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":26},"Semmelweis Egyetem, II. sz. Szemeszeti Klinika","Budapest","1085","Hungary","HU",{"type":36,"coordinates":90},[91,92],19.04045,47.49835,{"lat":92,"lon":91},{"facility":95,"status":26,"city":85,"state":26,"zip":96,"country":87,"countryCode":88,"cosmosGeoPoint":97,"geoPoint":99,"contacts":26},"Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika","1094",{"type":36,"coordinates":98},[91,92],{"lat":92,"lon":91},{"facility":101,"status":26,"city":85,"state":26,"zip":102,"country":87,"countryCode":88,"cosmosGeoPoint":103,"geoPoint":105,"contacts":26},"Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet","1097",{"type":36,"coordinates":104},[91,92],{"lat":92,"lon":91},{"facility":107,"status":26,"city":108,"state":109,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Instituto Nacional de Pediatria","Colonia Insurgentes Cuicuilco, Delegacion Coyoacan","Mexico City","04530","Mexico","MX",{"facility":114,"status":26,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":124,"contacts":26},"Medical Research Laboratory Philippine General Hospital University of the Philippines","Ermita","Manila","1000","Philippines","PH",{"type":36,"coordinates":121},[122,123],122.71667,10.9,{"lat":123,"lon":122},{"facility":126,"status":26,"city":116,"state":26,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":127,"geoPoint":131,"contacts":26},"Rm. 112 ICHHD, National Institutes of Health-University of the Philippines Manila",{"type":36,"coordinates":128},[129,130],120.9822,14.6042,{"lat":130,"lon":129},{"facility":133,"status":26,"city":134,"state":26,"zip":135,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":142,"contacts":26},"Oddzial Pediatryczny I- Hematologiczno-Onkologiczny","Olsztyn","10-561","Poland","PL",{"type":36,"coordinates":139},[140,141],20.49272,53.78376,{"lat":141,"lon":140},{"facility":144,"status":26,"city":145,"state":26,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":153,"contacts":26},"Detska fakultna nemocnica s poliklinikou Bratislava","Bratislava","833 40","Slovakia","SK",{"type":36,"coordinates":150},[151,152],17.10674,48.14816,{"lat":152,"lon":151},{"type":155,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100139974","phase-3-a-study-of-the-safety-tolerability-and-effective-of-voriconazole-for-the-treatment-of-serious-candida-infection-and-candida-infection-of-the-throat-in-pediatric-patients-100139974",true,"NCT01092832","A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients","A Prospective, Open-label, Non-comparative Study To Assess The Safety, Tolerability And Efficacy Of Voriconazole For The Primary And Salvage Treatment Of Invasive Candidiasis, Candidemia, And Esophageal Candidiasis In Pediatric Subjects","Inclusion Criteria:\n\n* Male or female 2 to \\\u003C18 years of age; Subjects 2 to \\\u003C12 years of age will be permitted to enroll in this study only after a Pfizer sponsored pharmacokinetic study confirms the proposed dosage corresponding to this age group is appropriate.\n* Patients with confirmed Candida infection of the blood, body tissues, or the esophagus.\n* Patient's doctor feels voriconazole is an appropriate choice of therapy.\n\nExclusion Criteria:\n\n* A known allergy to voriconazole or to azole to antifungal drugs.\n* Females who are pregnant, lactating (breast feeding) or planning a pregnancy during the course of the study, or who are of childbearing potential and not using highly effective method of birth control.\n* A patient who is receiving treatment with a drug know to interfere with the heart's electrical system (QTc prolongation).\n* A patient who is receiving treatment with a drug that is not permitted to be used with voriconazole.\n* For primary therapy: a patient who has received more than 48 hours of antifungal therapy for the current episode of Candida infection.\n* A patient with significant underlying liver disease at the time of enrollment in the study.\n* A patient with significant renal disease (CrCl \\\u003C 50 ml\u002Fmin) at the time of enrollment in the study.\n* A patient with a high likelihood of death within 72 hours of study enrollment due to factors unrelated to Candida infection.",false,"ALL","2 Years","17 Years",{"count":168,"type":169},23,"ACTUAL","INTERVENTIONAL",[172],"PHASE3","The purpose of this study is to determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents.",[175],"Candidiasis",[177],"Invasive Candidiasis Candidemia Esophageal Candidiasis","TERMINATED","This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.","2016-05-17",{"date":182,"type":183},"2016-06-23","ESTIMATED",{"date":185,"type":26},"2010-10",{"date":187,"type":169},"2013-06",{"name":5,"class":6},14]