Nctid:
NCT00000980
Payload:
{"FullStudy"=>{"Rank"=>473425, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000003457", "ConditionMeshTerm"=>"Cryptosporidiosis"}, {"ConditionMeshId"=>"D000003967", "ConditionMeshTerm"=>"Diarrhea"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000012817", "ConditionAncestorTerm"=>"Signs and Symptoms, Digestive"}, {"ConditionAncestorId"=>"D000007411", "ConditionAncestorTerm"=>"Intestinal Diseases, Parasitic"}, {"ConditionAncestorId"=>"D000010272", "ConditionAncestorTerm"=>"Parasitic Diseases"}, {"ConditionAncestorId"=>"D000011529", "ConditionAncestorTerm"=>"Protozoan Infections, Animal"}, {"ConditionAncestorId"=>"D000010273", "ConditionAncestorTerm"=>"Parasitic Diseases, Animal"}, {"ConditionAncestorId"=>"D000003048", "ConditionAncestorTerm"=>"Coccidiosis"}, {"ConditionAncestorId"=>"D000011528", "ConditionAncestorTerm"=>"Protozoan Infections"}, {"ConditionAncestorId"=>"D000007410", "ConditionAncestorTerm"=>"Intestinal Diseases"}, {"ConditionAncestorId"=>"D000005767", "ConditionAncestorTerm"=>"Gastrointestinal Diseases"}, {"ConditionAncestorId"=>"D000004066", "ConditionAncestorTerm"=>"Digestive System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9889", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17940", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3212", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6849", "ConditionBrowseLeafName"=>"Diarrhea", "ConditionBrowseLeafAsFound"=>"Diarrhea", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12515", "ConditionBrowseLeafName"=>"Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19100", "ConditionBrowseLeafName"=>"AIDS-Related Opportunistic Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6358", "ConditionBrowseLeafName"=>"Cryptosporidiosis", "ConditionBrowseLeafAsFound"=>"Cryptosporidiosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M15312", "ConditionBrowseLeafName"=>"Signs and Symptoms, Digestive", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10134", "ConditionBrowseLeafName"=>"Intestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10135", "ConditionBrowseLeafName"=>"Intestinal Diseases, Parasitic", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12875", "ConditionBrowseLeafName"=>"Parasitic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14078", "ConditionBrowseLeafName"=>"Protozoan Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5966", "ConditionBrowseLeafName"=>"Coccidioidomycosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5967", "ConditionBrowseLeafName"=>"Coccidiosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8573", "ConditionBrowseLeafName"=>"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6945", "ConditionBrowseLeafName"=>"Digestive System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1672", "ConditionBrowseLeafName"=>"Cryptosporidiosis", "ConditionBrowseLeafAsFound"=>"Cryptosporidiosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T1374", "ConditionBrowseLeafName"=>"Coccidioidomycosis", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Digestive System Diseases", "ConditionBrowseBranchAbbrev"=>"BC06"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000015572", "InterventionMeshTerm"=>"Spiramycin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000900", "InterventionAncestorTerm"=>"Anti-Bacterial Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000003049", "InterventionAncestorTerm"=>"Coccidiostats"}, {"InterventionAncestorId"=>"D000000981", "InterventionAncestorTerm"=>"Antiprotozoal Agents"}, {"InterventionAncestorId"=>"D000000977", "InterventionAncestorTerm"=>"Antiparasitic Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M17880", "InterventionBrowseLeafName"=>"Spiramycin", "InterventionBrowseLeafAsFound"=>"Cholestasis of Pregnancy", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3912", "InterventionBrowseLeafName"=>"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3904", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3988", "InterventionBrowseLeafName"=>"Antiprotozoal Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3984", "InterventionBrowseLeafName"=>"Antiparasitic Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"25"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 1990", "LastUpdateSubmitDate"=>"June 23, 2005", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"June 24, 2005", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Single-Blind Method", "Spiramycin", "AIDS-Related Opportunistic Infections", "Injections, Intravenous", "Cryptosporidiosis", "Diarrhea", "Drug Evaluation", "Acquired Immunodeficiency Syndrome"]}, "ConditionList"=>{"Condition"=>["Cryptosporidiosis", "HIV Infections"]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine the safety and effectiveness of intravenous spiramycin in patients with AIDS-related cryptosporidial diarrhea.\n\nSpiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin.", "DetailedDescription"=>"Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. Results of one study, however, showed no significant difference between spiramycin and placebo (inactive medication). A later study indicated that the absorption of spiramycin is significantly decreased when food is present. Thus, the results of the trial may have been due to poor absorption of spiramycin.\n\nPatients are observed for 3 days to establish baseline conditions. They are informed that the treatment period is 21 days during which they receive 15 days of spiramycin and 6 consecutive days of placebo; they are not told which 6-day period they receive placebo. All patients receive 15 days of spiramycin. Patients who do not have a favorable response are treated with a higher dose of spiramycin for an additional 15 days. Responders at either dose are followed weekly for 4 weeks. Should a relapse occur, patients receive an additional 15 days of therapy, at the dose of spiramycin that initially produced a response, following reestablishment of a baseline with 6 days of placebo. Nonresponders to the higher dose are taken off the study."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"13 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nVitamin supplements.\nZidovudine (AZT) for patients previously taking AZT. However, dosing with spiramycin should be delayed until the dose of AZT has stabilized. The dose may be decreased for AZT-associated toxicity.\n\nAllowed for diarrhea:\n\nLoperamide hydrochloride capsules (2 mg) or loperamide hydrochloride liquid (1 mg/5 ml).\n\nAllowed for nausea:\n\nSucralfate and metoclopramide hydrochloride.\n\nAllowed for vomiting:\n\nProchlorperazine and trimethobenzamide hydrochloride.\nAllowed as prophylaxis for Pneumocystis carinii pneumonia (PCP):\nAerosolized pentamidine.\n\nPatients must have:\n\nA diagnosis of AIDS according to the CDC.\nChronic diarrhea.\nPresence of Cryptosporidium oocysts in stool specimen. Patients or a legally authorized representative must sign an informed consent form. Diet will be lactose free, maximum 7 g fat/day with unlimited calorie intake. Patients who require total parenteral nutrition will also be allowed oral intake.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\nGrade 4 (for hematologic) or Grade 3 (for all other) toxicity.\nKnown sensitivity to macrolide antibiotics.\nPresence of other diarrhea-causing pathogens.\nActive opportunistic infection requiring systemic antimicrobial therapy.\nToxicity grades according to NIAID toxicity scale for adults.\n\nConcurrent Medication:\n\nExcluded:\n\nOther investigational drugs.\nCancer chemotherapy.\nAlpha interferon.\nOther immunomodulating agents.\nOther macrolide antibiotics.\nTrimethoprim / sulfamethoxazole.\nGanciclovir.\nH2 blockers and AL-721.\nMedications known to cause gastrointestinal irritation or alteration of gastrointestinal motility or absorption should be avoided if possible.\nZidovudine (AZT) therapy may not be initiated and the dose may not be increased during the study.\n\nPatients with the following are excluded:\n\nGrade 4 (for hematologic) or Grade 3 (for all other) toxicity.\nKnown sensitivity to macrolide antibiotics.\nPresence of other diarrhea-causing pathogens.\nActive opportunistic infection requiring systemic antimicrobial therapy.\nToxicity grades according to NIAID toxicity scale for adults.\n\nPrior Medication:\n\nExcluded within 7 days of study entry:\n\nInvestigational drugs.\n\nExcluded within 14 days of study entry:\n\nCancer chemotherapy.\nAlpha interferon.\nOther immunomodulating agents.\nOther macrolide antibiotics.\nTrimethoprim / sulfamethoxazole.\nGanciclovir."}, "IdentificationModule"=>{"NCTId"=>"NCT00000980", "BriefTitle"=>"A Study of Spiramycin in the Treatment of Patients With AIDS-Related Diarrhea", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 113"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"FDA 28A"}, {"SecondaryId"=>"CCB-301"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Spiramycin", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"92120", "LocationCity"=>"San Diego", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Kaiser Permanente Med Ctr"}, {"LocationZip"=>"21205", "LocationCity"=>"Baltimore", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Johns Hopkins Univ School of Medicine"}, {"LocationZip"=>"01655", "LocationCity"=>"Worcester", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Univ of Massachusetts Med Ctr"}, {"LocationZip"=>"10016", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Bellevue Hosp / New York Univ Med Ctr"}, {"LocationZip"=>"10021", "LocationCity"=>"New York", "LocationState"=>"New York", "LocationCountry"=>"United States", "LocationFacility"=>"Cornell Univ Med Ctr"}, {"LocationZip"=>"44106", "LocationCity"=>"Cleveland", "LocationState"=>"Ohio", "LocationCountry"=>"United States", "LocationFacility"=>"Univ Hosp of Cleveland / Case Western Reserve Univ"}, {"LocationZip"=>"75219", "LocationCity"=>"Dallas", "LocationState"=>"Texas", "LocationCountry"=>"United States", "LocationFacility"=>"Nelson Tebedo Community Clinic"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"R Soave", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Rhone-Poulenc Rorer", "LeadSponsorClass"=>"INDUSTRY"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "CollaboratorClass"=>"NIH"}]}}}}}}