[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100060654":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":7,"responsibleParty":12,"collaborators":7,"id":14,"slug":15,"hasResults":16,"nctId":17,"briefTitle":18,"officialTitle":19,"acronym":7,"eligibilityCriteria":20,"healthyVolunteers":16,"sex":21,"minAge":22,"maxAge":23,"enrollmentInfo":24,"targetDuration":7,"studyType":27,"phases":28,"briefSummary":30,"conditions":31,"keywords":33,"overallStatus":36,"whyStopped":7,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":7},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","Posaconazole oral suspension",{"type":13,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100060654","phase-2-pkpd-study-of-posaconazole-for-empiric-treatment-of-invasive-fungal-infections-in-neutropenic-patients-or-treatment-of-refractory-invasive-fungal-infections-study-p01893-100060654",false,"NCT00034671","PK\u002FPD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)","Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts","Inclusion Criteria:\n\n* A proven, either probable or possible invasive fungal infection which is refractory to standard antifungal therapies.\n* Subjects who received \\>72 hours of systemic empiric antibacterial therapy and are neutropenic (\\\u003C500 neutrophils per mm3 and, have had fever that has reached an oral temperature \\>38c (or \\>100.4f)twice in the last 48 hours, or\n\nhave a recurrence of fever (oral temperature, \\>38c or \\>100.4F) while receiving broad spectrum antibacterial therapy after prior resolution of fever while on antibacterial therapy.\n\n* Able to take oral medication or take medication via enteral feeding tube.","ALL","13 Years","65 Years",{"count":25,"type":26},98,"ACTUAL","INTERVENTIONAL",[29],"PHASE2","This phase II study will be conducted to:\n\n1. evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing schedules of Posaconazole in immunocompromised hosts with a variety of refractory invasive fungal infections or in subjects who require empiric antifungal therapy and\n2. identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population.",[32],"Mycoses",[34,35],"Aspergillosis, Candidiasis, Mucormycosis, Cryptococcosis","Invasive Fungal Infections","COMPLETED","2015-12-30",{"date":39,"type":40},"2015-12-31","ESTIMATED",{"date":42,"type":7},"2001-01",{"date":44,"type":26},"2002-03",{"name":5,"class":6}]