Nctid:
NCT00000938
Payload:
{"FullStudy"=>{"Rank"=>498394, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000008193", "ConditionMeshTerm"=>"Lyme Disease"}, {"ConditionMeshId"=>"D000077342", "ConditionMeshTerm"=>"Post-Lyme Disease Syndrome"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000016905", "ConditionAncestorTerm"=>"Gram-Negative Bacterial Infections"}, {"ConditionAncestorId"=>"D000001424", "ConditionAncestorTerm"=>"Bacterial Infections"}, {"ConditionAncestorId"=>"D000001423", "ConditionAncestorTerm"=>"Bacterial Infections and Mycoses"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000001899", "ConditionAncestorTerm"=>"Borrelia Infections"}, {"ConditionAncestorId"=>"D000013145", "ConditionAncestorTerm"=>"Spirochaetales Infections"}, {"ConditionAncestorId"=>"D000017282", "ConditionAncestorTerm"=>"Tick-Borne Diseases"}, {"ConditionAncestorId"=>"D000079426", "ConditionAncestorTerm"=>"Vector Borne Diseases"}, {"ConditionAncestorId"=>"D000094025", "ConditionAncestorTerm"=>"Post-Infectious Disorders"}, {"ConditionAncestorId"=>"D000002908", "ConditionAncestorTerm"=>"Chronic Disease"}, {"ConditionAncestorId"=>"D000020969", "ConditionAncestorTerm"=>"Disease Attributes"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11190", "ConditionBrowseLeafName"=>"Lyme Disease", "ConditionBrowseLeafAsFound"=>"Lyme Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M1779", "ConditionBrowseLeafName"=>"Post-Lyme Disease Syndrome", "ConditionBrowseLeafAsFound"=>"Chronic Lyme Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4722", "ConditionBrowseLeafName"=>"Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19249", "ConditionBrowseLeafName"=>"Gram-Negative Bacterial Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12136", "ConditionBrowseLeafName"=>"Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4721", "ConditionBrowseLeafName"=>"Bacterial Infections and Mycoses", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5177", "ConditionBrowseLeafName"=>"Borrelia Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19577", "ConditionBrowseLeafName"=>"Tick-Borne Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2054", "ConditionBrowseLeafName"=>"Vector Borne Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3014", "ConditionBrowseLeafName"=>"Post-Infectious Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6147", "ConditionBrowseLeafName"=>"Chronic Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M22700", "ConditionBrowseLeafName"=>"Disease Attributes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1303", "ConditionBrowseLeafName"=>"Chronic Graft Versus Host Disease", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000004318", "InterventionMeshTerm"=>"Doxycycline"}, {"InterventionMeshId"=>"D000002443", "InterventionMeshTerm"=>"Ceftriaxone"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000900", "InterventionAncestorTerm"=>"Anti-Bacterial Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000000962", "InterventionAncestorTerm"=>"Antimalarials"}, {"InterventionAncestorId"=>"D000000981", "InterventionAncestorTerm"=>"Antiprotozoal Agents"}, {"InterventionAncestorId"=>"D000000977", "InterventionAncestorTerm"=>"Antiparasitic Agents"}, {"InterventionAncestorId"=>"D000097911", "InterventionAncestorTerm"=>"Third Generation Cephalosporins"}, {"InterventionAncestorId"=>"D000097902", "InterventionAncestorTerm"=>"Beta Lactam Antibiotics"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M7493", "InterventionBrowseLeafName"=>"Doxycycline", "InterventionBrowseLeafAsFound"=>"Resources", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5693", "InterventionBrowseLeafName"=>"Ceftriaxone", "InterventionBrowseLeafAsFound"=>"Environmental", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M4222", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4280", "InterventionBrowseLeafName"=>"Antimalarials", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4298", "InterventionBrowseLeafName"=>"Antiprotozoal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4294", "InterventionBrowseLeafName"=>"Antiparasitic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5760", "InterventionBrowseLeafName"=>"Cephalosporins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3453", "InterventionBrowseLeafName"=>"Third Generation Cephalosporins", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10789", "InterventionBrowseLeafName"=>"Lactams", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25772", "InterventionBrowseLeafName"=>"beta-Lactams", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4224", "InterventionBrowseLeafName"=>"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3444", "InterventionBrowseLeafName"=>"Beta Lactam Antibiotics", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"66"}}, "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"=>["Lyme Disease"]}}, "DescriptionModule"=>{"BriefSummary"=>"Lyme disease is the most common tick-borne disease in the United States. It is caused by the spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1) persistent infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of coinfection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, in seronegative patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).", "DetailedDescription"=>"Sixty-six patients will be enrolled in this study. Each patient will be assigned to one of two groups and will be randomly selected to receive either antibiotic therapy or placebo; but, the assignment of medication will not be made known to the patient or administering doctor. Antibiotic or placebo will be given intravenously (IV) for 30 consecutive days and then orally for the next 60 consecutive days."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nYou may be eligible for this study if you:\n\nAre at least 18 years of age.\nAre seronegative for antibodies against B. burgdorferi antigens by Western Blot at enrollment.\nHave documented history of acute Lyme disease.\nHave had a rash (erythema migrans) that resembles a bullseye. This skin aberration usually occurs after a tick bite in late spring, summer, or early fall and is sometimes accompanied by fatigue, fever, headache, mild stiff neck, arthralgia or myalgia.\nHave had one or more clinical features typical of Lyme disease acquired in the United States (see technical summary)\nHave had one or more of the following symptoms and conditions that have persisted for at least 6 months (but less than 12 years) and are not attributable to another cause or condition: a) widespread musculoskeletal pain and fatigue that began coincident with or within 6 months following initial infection with B. burgdorferi. b) certain neurologic symptoms including memory impairment and nerve pain, beginning within 6 months following initial infection with B. burgdorferi.\nHave had a physician-documented history of prior antibiotic treatment with a currently recommended antibiotic regimen.\n\nExclusion Criteria:\n\nYou will not be eligible for this study if you:\n\nHave previously enrolled in this study.\nAre pregnant, lactating, or unable to use birth control measures during the treatment period of this study.\nAre taking chronic medication that could interfere with evaluation of symptoms.\nAre taking or have taken various medications that could interfere with the evaluation of symptoms (see technical summary).\nAre hypersensitive to ceftriaxone or doxycycline.\nHave active inflammatory synovitis.\nHave another disease that could account for symptoms of acute Lyme disease.\nHave another serious or active infection.\nAre unable to tolerate an IV.\nHave tested positive for Borrelia DNA in plasma or cerebrospinal fluid at the time of initial evaluation for study.\nHave tested seropositive by Western Blot (these patients may be offered enrollment in seropositive study)."}, "IdentificationModule"=>{"NCTId"=>"NCT00000938", "BriefTitle"=>"A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seronegative Chronic Lyme Disease", "OrgStudyIdInfo"=>{"OrgStudyId"=>"DMID 97-003"}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"ceftriaxone", "InterventionType"=>"Drug"}, {"InterventionName"=>"doxycycline", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"02111", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Mark Klempner"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}}}}}}