Nctid:
NCT00000980
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "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"=>"T1672", "name"=>"Cryptosporidiosis", "asFound"=>"Cryptosporidiosis", "relevance"=>"HIGH"}, {"id"=>"T1374", "name"=>"Coccidioidomycosis", "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"=>"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"=>"Waiting area", "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"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>25}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1990-10", "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"=>["Single-Blind Method", "Spiramycin", "AIDS-Related Opportunistic Infections", "Injections, Intravenous", "Cryptosporidiosis", "Diarrhea", "Drug Evaluation", "Acquired Immunodeficiency Syndrome"], "conditions"=>["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"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Vitamin supplements.\n* Zidovudine (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\n* Loperamide hydrochloride capsules (2 mg) or loperamide hydrochloride liquid (1 mg/5 ml).\n\nAllowed for nausea:\n\n* Sucralfate and metoclopramide hydrochloride.\n\nAllowed for vomiting:\n\n* Prochlorperazine and trimethobenzamide hydrochloride.\n* Allowed as prophylaxis for Pneumocystis carinii pneumonia (PCP):\n* Aerosolized pentamidine.\n\nPatients must have:\n\n* A diagnosis of AIDS according to the CDC.\n* Chronic diarrhea.\n* Presence 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\n* Grade 4 (for hematologic) or Grade 3 (for all other) toxicity.\n* Known sensitivity to macrolide antibiotics.\n* Presence of other diarrhea-causing pathogens.\n* Active opportunistic infection requiring systemic antimicrobial therapy.\n* Toxicity grades according to NIAID toxicity scale for adults.\n\nConcurrent Medication:\n\nExcluded:\n\n* Other investigational drugs.\n* Cancer chemotherapy.\n* Alpha interferon.\n* Other immunomodulating agents.\n* Other macrolide antibiotics.\n* Trimethoprim / sulfamethoxazole.\n* Ganciclovir.\n* H2 blockers and AL-721.\n* Medications known to cause gastrointestinal irritation or alteration of gastrointestinal motility or absorption should be avoided if possible.\n* Zidovudine (AZT) therapy may not be initiated and the dose may not be increased during the study.\n\nPatients with the following are excluded:\n\n* Grade 4 (for hematologic) or Grade 3 (for all other) toxicity.\n* Known sensitivity to macrolide antibiotics.\n* Presence of other diarrhea-causing pathogens.\n* Active opportunistic infection requiring systemic antimicrobial therapy.\n* Toxicity grades according to NIAID toxicity scale for adults.\n\nPrior Medication:\n\nExcluded within 7 days of study entry:\n\n* Investigational drugs.\n\nExcluded within 14 days of study entry:\n\n* Cancer chemotherapy.\n* Alpha interferon.\n* Other immunomodulating agents.\n* Other macrolide antibiotics.\n* Trimethoprim / sulfamethoxazole.\n* Ganciclovir."}, "identificationModule"=>{"nctId"=>"NCT00000980", "briefTitle"=>"A Study of Spiramycin in the Treatment of Patients With AIDS-Related Diarrhea", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Single-Blind Efficacy Evaluation of Intravenous Spiramycin in Subjects With AIDS-Related Cryptosporidial Diarrhea", "orgStudyIdInfo"=>{"id"=>"ACTG 113"}, "secondaryIdInfos"=>[{"id"=>"FDA 28A"}, {"id"=>"CCB-301"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Spiramycin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92120", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"Kaiser Permanente Med Ctr", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"21205", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Univ School of Medicine", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"01655", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Univ of Massachusetts Med Ctr", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Bellevue Hosp / New York Univ Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Cornell Univ Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"44106", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ Hosp of Cleveland / Case Western Reserve Univ", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"75219", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Nelson Tebedo Community Clinic", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}], "overallOfficials"=>[{"name"=>"R Soave", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Rhone-Poulenc Rorer", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}]}}}
