Nctid:
NCT00002062
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003457", "term"=>"Cryptosporidiosis"}, {"id"=>"D003967", "term"=>"Diarrhea"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D012817", "term"=>"Signs and Symptoms, Digestive"}, {"id"=>"D007411", "term"=>"Intestinal Diseases, Parasitic"}, {"id"=>"D010272", "term"=>"Parasitic Diseases"}, {"id"=>"D011529", "term"=>"Protozoan Infections, Animal"}, {"id"=>"D010273", "term"=>"Parasitic Diseases, Animal"}, {"id"=>"D003048", "term"=>"Coccidiosis"}, {"id"=>"D011528", "term"=>"Protozoan Infections"}, {"id"=>"D007410", "term"=>"Intestinal Diseases"}, {"id"=>"D005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M7159", "name"=>"Diarrhea", "asFound"=>"Diarrhea", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M6668", "name"=>"Cryptosporidiosis", "asFound"=>"Cryptosporidiosis", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M15622", "name"=>"Signs and Symptoms, Digestive", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M10445", "name"=>"Intestinal Diseases, Parasitic", "relevance"=>"LOW"}, {"id"=>"M13185", "name"=>"Parasitic Diseases", "relevance"=>"LOW"}, {"id"=>"M14388", "name"=>"Protozoan Infections", "relevance"=>"LOW"}, {"id"=>"M6276", "name"=>"Coccidioidomycosis", "relevance"=>"LOW"}, {"id"=>"M6277", "name"=>"Coccidiosis", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T1672", "name"=>"Cryptosporidiosis", "asFound"=>"Cryptosporidiosis", "relevance"=>"HIGH"}, {"id"=>"T1374", "name"=>"Coccidioidomycosis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015572", "term"=>"Spiramycin"}], "ancestors"=>[{"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D003049", "term"=>"Coccidiostats"}, {"id"=>"D000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000977", "term"=>"Antiparasitic Agents"}], "browseLeaves"=>[{"id"=>"M18190", "name"=>"Spiramycin", "asFound"=>"Scented", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1991-10", "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"=>["Spiramycin", "AIDS-Related Opportunistic Infections", "Immune Tolerance", "Cryptosporidiosis", "Diarrhea", "Drugs, Investigational", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Cryptosporidiosis", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"This protocol provides for the availability of spiramycin under compassionate-use conditions for the treatment of chronic diarrhea due to cryptosporidium in patients with a compromised immune system, thus deriving additional information regarding its safety and efficacy profile."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Exclusion Criteria\n\nCo-existing Condition:\n\nPatients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.\n\n* Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other investigational drugs.\n\nPatients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity.\n\n* Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study.\n\nPrior Medication:\n\nExcluded within 7 days of study entry:\n\n* Other investigational drugs.\n\nDiagnosis of chronic diarrhea due to cryptosporidiosis and a compromised immune system but not limited to patients with AIDS.\n\n* Patients receiving chemotherapy for a malignancy.\n* Patients who are iatrogenically immune-suppressed following organ transplantation."}, "identificationModule"=>{"nctId"=>"NCT00002062", "briefTitle"=>"Open-Label \"Compassionate\" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Open-Label \"Compassionate\" Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients", "orgStudyIdInfo"=>{"id"=>"011A"}, "secondaryIdInfos"=>[{"id"=>"CCA 901"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Spiramycin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"19044", "city"=>"Horsham", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Rhone - Poulenc Rorer Pharmaceuticals", "geoPoint"=>{"lat"=>40.17844, "lon"=>-75.12851}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Rhone-Poulenc Rorer", "class"=>"INDUSTRY"}}}}
