Nctid:
NCT00002283
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D011014", "term"=>"Pneumonia"}, {"id"=>"D011020", "term"=>"Pneumonia, Pneumocystis"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D008172", "term"=>"Lung Diseases, Fungal"}, {"id"=>"D009181", "term"=>"Mycoses"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D016720", "term"=>"Pneumocystis Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M13904", "name"=>"Pneumonia", "asFound"=>"Pneumonia", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M13910", "name"=>"Pneumonia, Pneumocystis", "asFound"=>"Pneumonia, Pneumocystis", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M11169", "name"=>"Lung Diseases, Fungal", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M19082", "name"=>"Pneumocystis Infections", "relevance"=>"LOW"}, {"id"=>"T4598", "name"=>"Pneumocystis Jirovecii Pneumonia", "asFound"=>"Pneumocystis", "relevance"=>"HIGH"}, {"id"=>"T4599", "name"=>"Pneumocystosis", "asFound"=>"Pneumocystis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D014295", "term"=>"Trimethoprim"}, {"id"=>"D003622", "term"=>"Dapsone"}, {"id"=>"D013420", "term"=>"Sulfamethoxazole"}], "ancestors"=>[{"id"=>"D000892", "term"=>"Anti-Infective Agents, Urinary"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000962", "term"=>"Antimalarials"}, {"id"=>"D000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D018726", "term"=>"Anti-Dyskinesia Agents"}, {"id"=>"D065687", "term"=>"Cytochrome P-450 CYP2C8 Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D007917", "term"=>"Leprostatic Agents"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}], "browseLeaves"=>[{"id"=>"M17047", "name"=>"Trimethoprim", "asFound"=>"Decision aid", "relevance"=>"HIGH"}, {"id"=>"M16206", "name"=>"Sulfamethoxazole", "asFound"=>"Twice per day", "relevance"=>"HIGH"}, {"id"=>"M18253", "name"=>"Trimethoprim, Sulfamethoxazole Drug Combination", "relevance"=>"LOW"}, {"id"=>"M6824", "name"=>"Dapsone", "asFound"=>"Creation", "relevance"=>"HIGH"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4280", "name"=>"Antimalarials", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Anti-Dyskinesia Agents", "abbrev"=>"AnDyAg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1989-08", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Trimethoprim-Sulfamethoxazole Combination", "AIDS-Related Opportunistic Infections", "Pneumonia, Pneumocystis carinii", "Dapsone", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Pneumonia, Pneumocystis Carinii", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"Evaluate the effectiveness rate of dapsone plus trimethoprim as a therapy for the first episode of Pneumocystis carinii pneumonia (PCP) in AIDS patients. Compare the rates and severity of adverse effects using dapsone versus trimethoprim - sulfamethoxazole (TMP / PurposeX). Establish relative toxicities with regard to suitability for outpatient treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Exclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).\n\nPatients with the following are excluded:\n\n* History of allergic reaction to dapsone.\n* Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).\n* Patients subsequently found to be glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.\n\nPrior Medication:\n\nExcluded:\n\n* Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).\n\nPatients who are glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.\n\nHospitalized patients with first episode of Pneumocystis carinii pneumonia (PCP) documented by GIEMSA or methenamine stain.\n\n* Patients must:\n* Be willing and able to give informed consent.\n* Be expected to survive 1 week without therapy.\n* Have less than 48 hours of treatment for Pneumocystis carinii pneumonia (PCP) for this episode."}, "identificationModule"=>{"nctId"=>"NCT00002283", "briefTitle"=>"A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Randomized Prospective Study of Dapsone Versus Trimethoprim-Sulfamethoxazole in the Treatment of First Episode Pneumocystis Carinii Pneumonia in AIDS Patients", "orgStudyIdInfo"=>{"id"=>"007A"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Trimethoprim", "type"=>"DRUG"}, {"name"=>"Sulfamethoxazole", "type"=>"DRUG"}, {"name"=>"Dapsone", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"08540", "city"=>"Princeton", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Jacobus Pharmaceutical Co", "geoPoint"=>{"lat"=>40.34872, "lon"=>-74.65905}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Jacobus Pharmaceutical", "class"=>"INDUSTRY"}}}}
