Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-29 @ 1:07 PM
Study NCT ID:
NCT00005668
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2000-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2010-08-26', 'studyFirstSubmitDate': '2000-05-18', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Aspergillosis', 'Lung Diseases, Fungal']}, 'descriptionModule': {'briefSummary': 'To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma.\n\nAspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.', 'detailedDescription': 'Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo (oral cyclodextrin solution) twice daily for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nYou may be eligible for this study if you:\n\n* Are 18 years of age or older.\n* Have been diagnosed with aspergilloma within the last month.\n* Have (or have a history of) at least one of the following:\n\n 1. positive test for Aspergillus species.\n 2. presence of antibodies to Aspergillus.\n* Are willing to participate in the study for 2 full years.\n* Are female and not pregnant.\n* Are not breast-feeding.\n* Agree to use barrier methods of birth control / contraception during the study and for 30 days after.\n\nExclusion Criteria:\n\nYou will not be eligible for this study if you:\n\n* Have a history of allergy to triazole or imidazole drugs.\n* Are unable to take oral medication.\n* Are not expected to live for more than a month.\n* Have had a lung biopsy indicating Aspergillus infection.\n* Have had radiation therapy within the last 6 months.\n* Require treatment with certain medications.\n* Received amphotericin, amphotericin lipid formulation, fluconazole, or itraconazole in the two weeks prior to study entry.\n* Received chemotherapy within the last 6 months.'}, 'identificationModule': {'nctId': 'NCT00005668', 'briefTitle': 'A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma', 'orgStudyIdInfo': {'id': 'DMID MSG 37'}, 'secondaryIdInfos': [{'id': 'DMID 96-199'}, {'id': 'NIH/09021'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Itraconazole oral solution', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mary Ellen Bradley', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}}}}