Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-27 @ 3:11 AM
Study NCT ID:
NCT00056368
Status:
COMPLETED
Last Update Posted:
2008-10-21
First Post:
2003-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D058387', 'term': 'Candidemia'}, {'id': 'D058365', 'term': 'Candidiasis, Invasive'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D016469', 'term': 'Fungemia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077612', 'term': 'Anidulafungin'}, {'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-17', 'studyFirstSubmitDate': '2003-03-11', 'studyFirstSubmitQcDate': '2003-03-11', 'lastUpdatePostDateStruct': {'date': '2008-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-03-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Candida blood stream infections', 'Candida infections', 'Candidemia', 'Invasive Candidiasis'], 'conditions': ['Candidiasis']}, 'referencesModule': {'references': [{'pmid': '17568028', 'type': 'DERIVED', 'citation': 'Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D, Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ; Anidulafungin Study Group. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007 Jun 14;356(24):2472-82. doi: 10.1056/NEJMoa066906.'}]}, 'descriptionModule': {'briefSummary': 'Anidulafungin is a medicine being developed for treatment of patients with certain kinds of fungal infections. These infections due to yeast (a type of fungus) in the mouth/esophagus, in the blood or in other areas within the body.', 'detailedDescription': 'Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Diagnosis of candidemia and/or other forms of invasive candidiasis.\n* Should not have received greater than 48 hours of systemic antifungal therapy.\n* Life expectancy should be greater than 72 hours.\n* Should not have received greater than one week of prophylactic azole therapy 30 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT00056368', 'briefTitle': 'The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase III, Double-Blind, Randomized, Multi-Center, Study of the Safety and Efficacy of Anidulafungin vs. Fluconazole in the Treatment of Patients With Candidemia and Other Forms of Invasive Candidiasis and Prevention of Complications.', 'orgStudyIdInfo': {'id': 'VER002-9'}, 'secondaryIdInfos': [{'id': 'A8851002'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Anidulafungin', 'type': 'DRUG'}, {'name': 'Fluconazole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19406', 'city': 'King of Prussia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Versicor, Inc.', 'geoPoint': {'lat': 40.08927, 'lon': -75.39602}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vicuron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}