[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100097325":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":32,"responsibleParty":55,"collaborators":57,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":31,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":31,"enrollmentInfo":74,"targetDuration":31,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":86,"whyStopped":31,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Itraconazole","EXPERIMENTAL","Itraconazole 5mg\u002Fkg\u002Fday for 24 weeks",[13],"Drug: Itraconazole",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo\u002Fday for 24 weeks",[13],[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Oral Itraconazole 5mg\u002Fkg\u002Fday or identical placebo for 24 weeks",[9,15],[25],"non applicable",[27],{"name":28,"affiliation":29,"role":30},"Shawn Aaron, MD","OHRI","PRINCIPAL_INVESTIGATOR",null,[33,46],{"facility":34,"status":31,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":31},"Shawn Aaron, The Ottawa Hospital-General Campus","Ottawa","Ontario","K1H 8L6","Canada","CA",{"type":41,"coordinates":42},"Point",[43,44],-75.69812,45.41117,{"lat":44,"lon":43},{"facility":47,"status":31,"city":48,"state":36,"zip":49,"country":38,"countryCode":39,"cosmosGeoPoint":50,"geoPoint":54,"contacts":31},"Felix Ratjen, The Hospital for Sick Children","Toronto","M5G 1X8",{"type":41,"coordinates":51},[52,53],-79.39864,43.70643,{"lat":53,"lon":52},{"type":56,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[58,60,62],{"name":59,"class":6},"The Hospital for Sick Children",{"name":61,"class":6},"Canadian Cystic Fibrosis Foundation",{"name":63,"class":6},"The Physicians' Services Incorporated Foundation","100097325","phase-4-treatment-of-aspergillus-fumigatus-a-fungal-infection-in-patients-with-cystic-fibrosis-100097325",true,"NCT00528190","Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis","Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled Trial","Inclusion Criteria\n\n* Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq\u002FL by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations\n* Patient must be known to be chronically colonized with Aspergillus fumigatus.\n* Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization.\n* 6 years of age and older\n* Patients must weigh at least 20 kg\n* Post-menarche females must be using an effective form of contraception.\n\nExclusion Criteria\n\n* Inability to give informed consent.\n* Respiratory culture positive for B.cepacia complex\n* Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization\n* Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization\n* Neutropenia, absolute neutrophil count\\< or = 1000 within a 3-day period prior to randomization\n* History of biliary cirrhosis documented by liver biopsy or imaging.\n* History of portal hypertension.\n* Investigational drug use within 30 days of randomization date.\n* History of alcohol, illicit drug or medication abuse within 1 year of randomization.\n* Women who are pregnant, breastfeeding or trying to conceive",false,"ALL","6 Years",{"count":75,"type":76},35,"ACTUAL","INTERVENTIONAL",[79],"PHASE4","This clinical trial will attempt to determine whether we can improve clinical outcomes for patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.",[82],"Cystic Fibrosis",[82,84,85],"Aspergillus Fumigatus","randomized controlled clinical trials","COMPLETED","2017-04-03",{"date":89,"type":76},"2017-05-10",{"date":91,"type":31},"2007-10",{"date":93,"type":76},"2011-05",{"name":5,"class":6},2]