Nctid:
NCT00000778
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-28"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D014376", "term"=>"Tuberculosis"}, {"id"=>"D014397", "term"=>"Tuberculosis, Pulmonary"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D009164", "term"=>"Mycobacterium Infections"}, {"id"=>"D000193", "term"=>"Actinomycetales Infections"}, {"id"=>"D016908", "term"=>"Gram-Positive Bacterial Infections"}, {"id"=>"D001424", "term"=>"Bacterial Infections"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M17127", "name"=>"Tuberculosis", "asFound"=>"Tuberculosis", "relevance"=>"HIGH"}, {"id"=>"M17147", "name"=>"Tuberculosis, Pulmonary", "asFound"=>"Pulmonary Tuberculosis", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M12119", "name"=>"Mycobacterium Infections", "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"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D011736", "term"=>"Pyridoxine"}, {"id"=>"D025101", "term"=>"Vitamin B 6"}, {"id"=>"D064704", "term"=>"Levofloxacin"}, {"id"=>"D007538", "term"=>"Isoniazid"}], "ancestors"=>[{"id"=>"D000892", "term"=>"Anti-Infective Agents, Urinary"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D065609", "term"=>"Cytochrome P-450 CYP1A2 Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000995", "term"=>"Antitubercular Agents"}, {"id"=>"D054872", "term"=>"Fatty Acid Synthesis Inhibitors"}, {"id"=>"D000960", "term"=>"Hypolipidemic Agents"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D057847", "term"=>"Lipid Regulating Agents"}, {"id"=>"D014803", "term"=>"Vitamin B Complex"}, {"id"=>"D014815", "term"=>"Vitamins"}, {"id"=>"D018977", "term"=>"Micronutrients"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M30370", "name"=>"Levofloxacin", "asFound"=>"Thyroid", "relevance"=>"HIGH"}, {"id"=>"M17946", "name"=>"Ofloxacin", "relevance"=>"LOW"}, {"id"=>"M23026", "name"=>"Vitamin B 6", "asFound"=>"Beck Depression Inventory", "relevance"=>"HIGH"}, {"id"=>"M14583", "name"=>"Pyridoxal", "relevance"=>"LOW"}, {"id"=>"M14589", "name"=>"Pyridoxine", "asFound"=>"Beck Depression Inventory", "relevance"=>"HIGH"}, {"id"=>"M10570", "name"=>"Isoniazid", "asFound"=>"Granules", "relevance"=>"HIGH"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M29348", "name"=>"Topoisomerase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4311", "name"=>"Antitubercular Agents", "relevance"=>"LOW"}, {"id"=>"M4278", "name"=>"Hypolipidemic Agents", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M28883", "name"=>"Lipid Regulating Agents", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"T474", "name"=>"Vitamin B6", "asFound"=>"Beck Depression Inventory", "relevance"=>"HIGH"}, {"id"=>"T459", "name"=>"Pyridoxal", "relevance"=>"LOW"}, {"id"=>"T461", "name"=>"Pyridoxine", "asFound"=>"INR", "relevance"=>"HIGH"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Lipid Regulating Agents", "abbrev"=>"Lipd"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>44}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1995-06", "lastUpdateSubmitDate"=>"2008-08-06", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2008-08-08", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Isoniazid", "Tuberculosis, Pulmonary", "Pyridoxine", "Ofloxacin", "AIDS-Related Opportunistic Infections", "Drug Evaluation", "Acquired Immunodeficiency Syndrome", "Sputum", "Colony Count, Microbial"], "conditions"=>["HIV Infections", "Tuberculosis"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"El-Sadr WM, Perlman DC, Matts JP, Nelson E, Cohn D, Telzak E, Chirgwin K, Salomon N, Olibrice M, Hafner R. Outcome of an induction regimen for the treatment of HIV-related tuberculosis (TB): evaluation of the addition of a quinolone. Int Conf AIDS. 1996 Jul 7-12;11(1):327 (abstract no TuB2358)"}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the methodology for rapidly determining the early bactericidal activity (EBA), tolerance, and pharmacokinetics of isoniazid and levofloxacin in the treatment of pulmonary tuberculosis (TB).\n\nTraditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.", "detailedDescription"=>"Traditionally, in trials for treatment of TB, a new drug is administered in combination with two or more other antituberculous agents of known effectiveness over a long period of time. In this setting, it is difficult to determine the effect of any single drug or dose level. Development of new agents for the treatment of TB may be accelerated by a methodology in which a new agent could be evaluated for activity by administering it as a single agent over a short time period. This study utilizes a method to measure the amount of bacteria present each day in the lungs.\n\nAn initial cohort of patients receive isoniazid (with pyridoxine) daily for 5 days. Sputum samples are collected daily for determination of the EBA (decline in colony-forming units/ml sputum). If the methodology is validated, additional patients are randomized to receive one of two doses of levofloxacin daily for 5 days, with determination of EBA. All patients are hospitalized for 2 days of baseline evaluation and 5 days of treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed in all patients:\n\n* Antacids if administered more than 2 hours before or after study drug.\n\nAllowed in isoniazid patients:\n\n* Anticonvulsant therapy if blood levels are monitored.\n\nAllowed in levofloxacin patients:\n\n* Acceptable medications other than antacids if administered at least 2 hours before or 1 hour after study drug.\n* Anticonvulsant therapy, theophylline, or warfarin if doses are monitored.\n\nPatients must have:\n\n* Presumptive active pulmonary TB.\n* No clinical evidence of central nervous system or miliary tuberculosis.\n\nNOTE:\n\n* Both HIV-positive and HIV-negative patients are eligible.\n\nNOTE:\n\n* Pregnant women may be enrolled in the isoniazid cohort only.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Active or suspected MAI infection.\n* Active or suspected hepatitis.\n* Any other serious acute infection, diabetes, chronic obstructive pulmonary disease, malignancy requiring chemotherapy, or major organ dysfunction.\n* Extreme illness or toxic appearance.\n* Pregnancy (if entering the levofloxacin portion of the study).\n\nConcurrent Medication:\n\nExcluded:\n\n* All standard TB therapies.\n* Clofazimine.\n* Rifabutin.\n* Quinolones.\n* Aminoglycosides.\n* Corticosteroids.\n* Pentoxifylline.\n* Colony-stimulating factors.\n* Interferons.\n* Interleukins.\n* Disulfiram (patients receiving isoniazid).\n\nPatients with the following prior conditions are excluded:\n\n* History of treatment-limiting intolerance or known hypersensitivity to isoniazid (in patients receiving isoniazid) or to quinolones (in patients receiving levofloxacin).\n* Vomiting or diarrhea \\>= grade 2 at screening or within 2 days prior to screening.\n* History of drug-resistant TB (in patients receiving isoniazid).\n\nPrior Medication:\n\nExcluded:\n\n* Any prior treatment or prophylaxis for TB if enrolling on the isoniazid cohort.\n* Any anti-TB drug within the past 12 weeks, including standard drugs against TB as well as clofazimine, rifabutin, and all quinolones and aminoglycosides.\n* Corticosteroids, pentoxifylline, colony-stimulating factors, interferons, or interleukins within the past 12 weeks.\n\nKnown risk factors for multi-drug resistant (MDR) TB, including:\n\n* Domicile, shelter, or prison exposure to a known case of MDR TB within the past 6 months.\n* Residence in a specific domicile, shelter, or prison cell block within 6 months of a known outbreak of MDR TB.\n* Hospitalization, within the past 6 months, on a medical service or unit in which nosocomial transmission of MDR TB is known to have occurred."}, "identificationModule"=>{"nctId"=>"NCT00000778", "briefTitle"=>"A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin", "orgStudyIdInfo"=>{"id"=>"DATRI 008"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Isoniazid", "type"=>"DRUG"}, {"name"=>"Pyridoxine hydrochloride", "type"=>"DRUG"}, {"name"=>"Levofloxacin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"352336505", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Univ of Alabama at Birmingham", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"900951793", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90502", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor - UCLA Med Ctr", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"zip"=>"33316", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"Broward Gen Med Ctr", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami / Jackson Memorial Hosp", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"60622", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ of Illinois", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"701122699", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane Univ Med School", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"75235", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas Southwestern Med Ctr of Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"77550", "city"=>"Galveston", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ TX Galveston", "geoPoint"=>{"lat"=>29.30135, "lon"=>-94.7977}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Baylor College of Medicine / Houston Veterans Adm Med Ctr", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}], "overallOfficials"=>[{"name"=>"Hafner R", "role"=>"STUDY_CHAIR"}, {"name"=>"Cohn J", "role"=>"STUDY_CHAIR"}, {"name"=>"Egorin M", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}