Nctid:
NCT00001107
Payload:
{"FullStudy"=>{"Rank"=>492653, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"May 03, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000002177", "ConditionMeshTerm"=>"Candidiasis"}, {"ConditionMeshId"=>"D000009181", "ConditionMeshTerm"=>"Mycoses"}, {"ConditionMeshId"=>"D000072742", "ConditionMeshTerm"=>"Invasive Fungal Infections"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000001423", "ConditionAncestorTerm"=>"Bacterial Infections and Mycoses"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5437", "ConditionBrowseLeafName"=>"Candidiasis", "ConditionBrowseLeafAsFound"=>"Candidiasis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12136", "ConditionBrowseLeafName"=>"Mycoses", "ConditionBrowseLeafAsFound"=>"Fungal Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M1099", "ConditionBrowseLeafName"=>"Invasive Fungal Infections", "ConditionBrowseLeafAsFound"=>"Invasive Fungal Infections", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4722", "ConditionBrowseLeafName"=>"Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4721", "ConditionBrowseLeafName"=>"Bacterial Infections and Mycoses", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000015725", "InterventionMeshTerm"=>"Fluconazole"}, {"InterventionMeshId"=>"C000068538", "InterventionMeshTerm"=>"Liposomal amphotericin B"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000935", "InterventionAncestorTerm"=>"Antifungal Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000058888", "InterventionAncestorTerm"=>"14-alpha Demethylase Inhibitors"}, {"InterventionAncestorId"=>"D000065607", "InterventionAncestorTerm"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000065088", "InterventionAncestorTerm"=>"Steroid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000006727", "InterventionAncestorTerm"=>"Hormone Antagonists"}, {"InterventionAncestorId"=>"D000006730", "InterventionAncestorTerm"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000065688", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2C9 Inhibitors"}, {"InterventionAncestorId"=>"D000065689", "InterventionAncestorTerm"=>"Cytochrome P-450 CYP2C19 Inhibitors"}, {"InterventionAncestorId"=>"D000000981", "InterventionAncestorTerm"=>"Antiprotozoal Agents"}, {"InterventionAncestorId"=>"D000000977", "InterventionAncestorTerm"=>"Antiparasitic Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M11110", "InterventionBrowseLeafName"=>"Liver Extracts", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4002", "InterventionBrowseLeafName"=>"Amphotericin B", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M255436", "InterventionBrowseLeafName"=>"Liposomal amphotericin B", "InterventionBrowseLeafAsFound"=>"Yeast", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M18296", "InterventionBrowseLeafName"=>"Fluconazole", "InterventionBrowseLeafAsFound"=>"Remaining", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M6252", "InterventionBrowseLeafName"=>"Clotrimazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M11796", "InterventionBrowseLeafName"=>"Miconazole", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4254", "InterventionBrowseLeafName"=>"Antifungal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7951", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M30537", "InterventionBrowseLeafName"=>"Cytochrome P-450 Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9789", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9788", "InterventionBrowseLeafName"=>"Hormone Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4298", "InterventionBrowseLeafName"=>"Antiprotozoal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4294", "InterventionBrowseLeafName"=>"Antiparasitic Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Hematinics", "InterventionBrowseBranchAbbrev"=>"Hemat"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 4"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Prevention"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"500"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 2005", "CompletionDateStruct"=>{"CompletionDate"=>"November 2005"}, "LastUpdateSubmitDate"=>"August 26, 2010", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"August 27, 2010", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Candidiasis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"19144094", "ReferenceType"=>"derived", "ReferenceCitation"=>"Hadley S, Huckabee C, Pappas PG, Daly J, Rabkin J, Kauffman CA, Merion RM, Karchmer AW. Outcomes of antifungal prophylaxis in high-risk liver transplant recipients. Transpl Infect Dis. 2009 Feb;11(1):40-8. doi: 10.1111/j.1399-3062.2008.00361.x. Epub 2008 Dec 19."}]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to compare the safety and effectiveness of 2 treatments to prevent invasive fungal infections (IFI), which are infections caused by yeasts and molds that are common in patients with weak immune systems or transplant patients. AmBisome, a new treatment, will be compared to fluconazole, the traditional treatment for fungal infections caused by the yeast Candida. Treatment will only be given to liver transplant patients who are found to be at high risk for IFI. Liver transplant patients who are at low risk for IFI will be monitored but will receive no study medication.\n\nIFIs are found mainly in a high risk group of liver transplant patients, and are not common in those with low risk. If IFI preventive therapy is focused on the high risk group, there may be a lesser chance of Candida becoming resistant (able to grow despite the presence of drugs used to kill it). Treating only the high risk group will also save money.", "DetailedDescription"=>"If you are in the high risk group you will be assigned randomly (like tossing a coin) to receive either AmBisome or fluconazole. If you are in the low risk group, you will not receive any treatment. Both groups will be monitored for IFIs. The study will last for 100 days following your liver transplant."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nYou may be eligible for this study if you:\n\nHave had a liver transplant within 5 days of enrollment and agree to receive tacrolimus.\n\nExclusion Criteria:\n\nYou will not be eligible for this study if you:\n\nAre HIV-positive.\nHave a history of invasive fungal infection.\nHave received antifungal agents within 14 days prior to your liver transplant.\nAre allergic to azoles, amphotericin B, or tacrolimus."}, "IdentificationModule"=>{"NCTId"=>"NCT00001107", "BriefTitle"=>"Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Invasive Fungal Infection in Liver Transplant Recipients: A Randomized Double-Blind Trial Comparing AmBisome and Fluconazole in the High Risk Group and an Observational Cohort Study in the Low Risk", "OrgStudyIdInfo"=>{"OrgStudyId"=>"DMID 98-014"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"MSG #44"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Fluconazole", "InterventionType"=>"Drug"}, {"InterventionName"=>"AmBisome", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"35294", "LocationCity"=>"Birmingham", "LocationState"=>"Alabama", "LocationCountry"=>"United States", "LocationFacility"=>"Mary Ellen Bradley"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}}}}}}
