Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT01417169
Status:
UNKNOWN
Last Update Posted:
2014-07-14
First Post:
2011-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077551', 'term': 'Micafungin'}], 'ancestors': [{'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-11', 'studyFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2011-08-15', 'lastUpdatePostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence rate of IFDs assessed by physical examination and serum galactomannan test', 'timeFrame': '4 weeks', 'description': 'Absence of proven, probable, possible invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of Micafungin prophyalxis after HSCT'}], 'secondaryOutcomes': [{'measure': 'Survival rate', 'timeFrame': '100 days', 'description': 'IFD-related mortality'}, {'measure': 'Safety assessed by lab-test and adverse events', 'timeFrame': '4 weeks', 'description': 'Safety profiles'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neutropenia', 'Fungal Disease']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.', 'detailedDescription': 'The purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis after Autologous hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. Patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. Safety profile of micafungin is also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients will receive autologous hematopoietic stem cell transplantation including 2nd autologous transplantation\n2. Under 21 years old, pediatric, adolescent patients.\n\nExclusion Criteria:\n\n1. Aspartate transaminase or alanine transaminase level \\> 5 times UNL\n2. Bilirubin \\> 2.5 times UNL\n3. History of allergy, sensitivity, or any serious reaction to an echinocandin\n4. Invasive fungal disease at the time of enrolment\n5. Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug\n6. Positive pregnancy test'}, 'identificationModule': {'nctId': 'NCT01417169', 'briefTitle': 'Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'SNUCH-1102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Micafungin', 'interventionNames': ['Drug: micafungin']}], 'interventions': [{'name': 'micafungin', 'type': 'DRUG', 'otherNames': ['Micafungin sodium', 'Mycamine'], 'description': 'Eligible patients who provided informed consent form will be administered micafungin at 50 mg/day (1mg/kg/day for patients weighting \\<50kg) as 1-h infusion. Infusion of Micafungin will be started on the day -2 of the conditioning course of autologous stem cell transplantation', 'armGroupLabels': ['Micafungin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Chongno-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyoung Jin Kang, M.D, Ph.D', 'role': 'CONTACT', 'email': 'kanghj@snu.ac.kr', 'phone': '82 2 2072 3304'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyoung Jin Kang, M.D, Ph.D', 'role': 'CONTACT', 'email': 'kanghj@snu.ac.kr', 'phone': '82 2 2072 3304'}, {'name': 'Hyery Kim, M.D.', 'role': 'CONTACT', 'email': 'taban@hanmail.net', 'phone': '82 2 2072 0177'}], 'overallOfficials': [{'name': 'Hyoung Jin Kang, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}}}}