Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-25 @ 1:10 PM
Study NCT ID:
NCT01188759
Status:
WITHDRAWN
Last Update Posted:
2012-05-11
First Post:
2010-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Egypt', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D055744', 'term': 'Invasive Pulmonary Aspergillosis'}, {'id': 'D020953', 'term': 'Neuroaspergillosis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D055732', 'term': 'Pulmonary Aspergillosis'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020314', 'term': 'Central Nervous System Fungal Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065819', 'term': 'Voriconazole'}, {'id': 'D000077612', 'term': 'Anidulafungin'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-10', 'studyFirstSubmitDate': '2010-08-24', 'studyFirstSubmitQcDate': '2010-08-24', 'lastUpdatePostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Rate of all-cause mortality at 6 weeks', 'timeFrame': '6 weeks'}, {'measure': 'Rate of all-cause mortality at EOT', 'timeFrame': '12 weeks'}, {'measure': 'Global response to therapy at 6 weeks', 'timeFrame': '6 weeks'}, {'measure': 'Global response to therapy at EOT', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aspergillosis', 'Combination Therapy', 'Voriconazole', 'Anidulafungin'], 'conditions': ['Aspergillosis', 'Invasive Pulmonary Aspergillosis', 'Neuroaspergillosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501095&StudyName=Voriconazole%20And%20Anidulafungin%20Combination%20For%20Invasive%20Aspergillosis%20In%20Pediatric%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of proven, probable, or possible invasive aspergillosis.\n* Hematologic malignancy or allogeneic hematopoetic stem cell transplant.\n\nExclusion Criteria:\n\n* Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.\n* Chronic invasive aspergillosis.\n* Receipt of antifungal treatment for more than 96 hours.\n* Severe liver dysfunction.'}, 'identificationModule': {'nctId': 'NCT01188759', 'briefTitle': 'Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Prospective, Randomized Trial Comparing The Safety, Tolerability, And Efficacy Of Voriconazole And Anidulafungin In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Invasive Aspergillosis in Pediatric Subjects Aged 2 to 17 Years', 'orgStudyIdInfo': {'id': 'A1501095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Voriconazole and Anidulafungin Combination', 'description': 'Subjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy.', 'interventionNames': ['Drug: Voriconazole', 'Drug: Anidulafungin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voriconazole Monotherapy', 'description': 'Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.', 'interventionNames': ['Drug: Voriconazole']}], 'interventions': [{'name': 'Voriconazole', 'type': 'DRUG', 'description': 'For Children aged 2-11 years and adolescents aged 12-14 years weighing \\<50 kg:\n\nVoriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days.\n\nFor adolescents aged 12-17 years, excluding 12-14-year-olds weighing \\<50kg:\n\nVoriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days.\n\nVoriconazole therapy is to be given for 6-12 weeks.', 'armGroupLabels': ['Voriconazole and Anidulafungin Combination']}, {'name': 'Anidulafungin', 'type': 'DRUG', 'description': 'Anidulafungin 3 mg/kg IV load q24h x 24h (maximum 200 mg), then 1.5 mg/kg q24h (maximum 100 mg).\n\nAnidulafungin therapy is to be given for 2-4 weeks in combination with voriconazole.', 'armGroupLabels': ['Voriconazole and Anidulafungin Combination']}, {'name': 'Voriconazole', 'type': 'DRUG', 'description': 'For Children aged 2-11 years and adolescents aged 12-14 years weighing \\<50 kg:\n\nVoriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days.\n\nFor adolescents aged 12-17 years, excluding 12-14-year-olds weighing \\<50kg:\n\nVoriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days.\n\nVoriconazole therapy is to be given for 6-12 weeks.', 'armGroupLabels': ['Voriconazole Monotherapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}