Nctid:
NCT00001318
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000009164", "term"=>"Mycobacterium Infections"}, {"id"=>"D000009165", "term"=>"Mycobacterium Infections, Nontuberculous"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000000193", "term"=>"Actinomycetales Infections"}, {"id"=>"D000016908", "term"=>"Gram-Positive Bacterial Infections"}, {"id"=>"D000001424", "term"=>"Bacterial Infections"}, {"id"=>"D000001423", "term"=>"Bacterial Infections and Mycoses"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M12119", "name"=>"Mycobacterium Infections", "asFound"=>"Mycobacterium Infections", "relevance"=>"HIGH"}, {"id"=>"M12120", "name"=>"Mycobacterium Infections, Nontuberculous", "asFound"=>"Mycobacterium Infections, Atypical", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M19252", "name"=>"Gram-Positive Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000007372", "term"=>"Interferons"}, {"id"=>"D000007371", "term"=>"Interferon-gamma"}], "ancestors"=>[{"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M10407", "name"=>"Interferons", "asFound"=>"Water", "relevance"=>"HIGH"}, {"id"=>"M10406", "name"=>"Interferon-gamma", "asFound"=>"Cardiac output", "relevance"=>"HIGH"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1992-08"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-08", "completionDateStruct"=>{"date"=>"2000-11"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Immune Adjuvant", "Phagocytes", "Non-tuberculous Mycobacterial Infection"], "conditions"=>["Healthy", "Mycobacterium Infections, Atypical"]}, "referencesModule"=>{"references"=>[{"pmid"=>"3086725", "type"=>"BACKGROUND", "citation"=>"Nathan CF, Kaplan G, Levis WR, Nusrat A, Witmer MD, Sherwin SA, Job CK, Horowitz CR, Steinman RM, Cohn ZA. Local and systemic effects of intradermal recombinant interferon-gamma in patients with lepromatous leprosy. N Engl J Med. 1986 Jul 3;315(1):6-15. doi: 10.1056/NEJM198607033150102."}, {"pmid"=>"3880852", "type"=>"BACKGROUND", "citation"=>"Horsburgh CR Jr, Mason UG 3rd, Farhi DC, Iseman MD. Disseminated infection with Mycobacterium avium-intracellulare. A report of 13 cases and a review of the literature. Medicine (Baltimore). 1985 Jan;64(1):36-48. doi: 10.1097/00005792-198501000-00003."}, {"pmid"=>"7908719", "type"=>"BACKGROUND", "citation"=>"Holland SM, Eisenstein EM, Kuhns DB, Turner ML, Fleisher TA, Strober W, Gallin JI. Treatment of refractory disseminated nontuberculous mycobacterial infection with interferon gamma. A preliminary report. N Engl J Med. 1994 May 12;330(19):1348-55. doi: 10.1056/NEJM199405123301904."}]}, "descriptionModule"=>{"briefSummary"=>"This is an open label study to determine the effects of the administration of Interferon-gamma on the clinical condition and immune function of patients with severe, treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year. We may also collect blood from the relatives of these patients and normal volunteers in order to characterize the genetic basis, if any, of our patients' disorders.", "detailedDescription"=>"This is an open label study to determine the effects of the administration of Interferon-gamma on the clinical condition and immune function of patients with severe, treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year. We may also collect blood from the relatives of these patients and normal volunteers in order to characterize the genetic basis, if any, of our patients' disorders."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Demonstrated non-tuberculous mycobacterial infection, either disseminated or pulmonary.\n\nReceived medical treatment for at least 3 months without improvement.\n\nPreserved renal, hepatic and hematologic function.\n\nNegative pregnancy urine and effective contraceptive.\n\nAge range greater than 5.\n\nNo secondary immunodeficiency such as HIV or malignancy.\n\nNot currently receiving cytotoxic therapy within the past 3 months.\n\nNot pregnant or lactating.\n\nNo seizure disorders.\n\nNo known symptomatic cardiac disease."}, "identificationModule"=>{"nctId"=>"NCT00001318", "briefTitle"=>"Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma", "orgStudyIdInfo"=>{"id"=>"920255"}, "secondaryIdInfos"=>[{"id"=>"92-I-0255"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"interferon gamma", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}
