Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-28 @ 4:52 AM
Study NCT ID:
NCT00690092
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2008-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-center Study of Spherule-Derived Coccidioidin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003047', 'term': 'Coccidioidomycosis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2008-06-02', 'studyFirstSubmitQcDate': '2008-06-03', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the ability of spherule-derived coccidioidin to detect cellular hypersensitivity to C. immitis by a positive DTH skin test in a population with a history of pulmonary coccidioidomycosis.', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Determine the specificity of spherule-derived coccidioidin by testing the skin test antigen in naive adult volunteer and volunteers with a history of pulmonary histoplasmosis.', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coccidioidin', 'Coccidioidin SD', 'Spherule-derived coccidioidin', 'Coccidioidomycosis', 'Valley Fever', 'Coccidioides immitis'], 'conditions': ['Coccidioidomycosis']}, 'descriptionModule': {'briefSummary': 'Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test antigen was evaluated in three different populations of adult volunteers to determine the safety and efficacy of the product in the assessment of delayed-type hypersensitivity to Coccidioides immitis. Induration greater than or equal to 5 mm after 48 hours was considered positive for exposure to C. immitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good Health (absence of active medical disease)\n* Meets criteria specific to population groups:\n\n * Coccidioidomycosis Group:\n* History of coccidioidomycosis of at least 45 days duration confirmed by roentgenograph serologic or mycologic findings\n\n * Histoplasmosis Group:\n* History of pulmonary histoplasmosis\n\n * Naive Control Group:\n* Lifetime residence in the states of WA, OR, ID, or MT\n* Never employed as an agricultural worker\n* Serology negative for C.immitis antibodies\n\nExclusion Criteria (All Groups):\n\n* Active medical disease\n* Alcohol abuse or illicit drug use\n* Influenza-like illness within the past 4 weeks\n* Immunizations within the past 4 weeks\n* Current atopic or contact dermatitis, psoriasis, erythema nodosum, urticaria\n* Current treatment with corticosteroids, cytotoxic or immunosuppressive drugs\n* Immunodeficiency disease\n* HIV infection\n* Previous skin test with coccidioidin or SD Coccidioidin\n* Pregnant or lactating\n* Adverse reaction to thimerosal\n* Adverse reaction to Candida or Trichophyton skin test antigens\n\nCoccidioidomycosis Group:\n\n* Current cavitary or disseminated coccidioidomycosis\n* History of histoplasmosis, or blastomycosis\n\nHistoplasmosis Group:\n\n* History of coccidioidomycosis or blastomycosis\n\nNaive Control Group:\n\n* History of coccidioidomycosis, histoplasmosis, blastomycosis\n* Travel for more than 30 days in designated areas of CA, AZ, NV, UT, NM, TX and Mexico, Central and South America. Travel for more than 7 days in restricted areas of CA, AZ and TX.'}, 'identificationModule': {'nctId': 'NCT00690092', 'briefTitle': 'A Multi-center Study of Spherule-Derived Coccidioidin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nielsen BioSciences, Inc.'}, 'officialTitle': 'Safety, Sensitivity and Specificity of Spherule-derived Coccidioidin in Naive Adults, in Adults With a History of Pulmonary Coccidioidomycosis and in Adults With a History of Pulmonary Histoplasmosis', 'orgStudyIdInfo': {'id': 'S104-1, S104-2, S104-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.', 'interventionNames': ['Biological: Spherule-derived coccidioidin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive).', 'interventionNames': ['Biological: Spherule-derived coccidioidin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology.', 'interventionNames': ['Biological: Spherule-derived coccidioidin']}], 'interventions': [{'name': 'Spherule-derived coccidioidin', 'type': 'BIOLOGICAL', 'otherNames': ['Coccidioidin SD (proposed trade name)'], 'description': '1.27 ug of sterile, injectable product (spherule-derived coccidioidin). Product was administered once by intradermal injection along with positive and negative control agents and results read after 48 hours.', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Health Sciences Center AVAHCS, Univ. of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93306', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Kern Facility Medical Group', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '68001', 'city': 'Blair', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Blair Clinic', 'geoPoint': {'lat': 41.54444, 'lon': -96.12502}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Spokane Allergy and Asthma Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Harry S Nielsen, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nielsen BioSciences, Inc.'}, {'name': 'Royce Johnson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kern Medical Center'}, {'name': 'Neil Ampel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona, Tucson'}, {'name': 'Brad Sawtelle, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Blair, NE'}, {'name': 'Stephen Kernerman, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spokane, WA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nielsen BioSciences, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sr Consultants Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Harry S. Nielsen, Ph.D.', 'oldOrganization': 'Allermed Laboratories, Inc.'}}}}