Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT01040156
Status:
COMPLETED
Last Update Posted:
2009-12-29
First Post:
2009-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536777', 'term': 'Systemic candidiasis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-28', 'studyFirstSubmitDate': '2009-12-28', 'studyFirstSubmitQcDate': '2009-12-28', 'lastUpdatePostDateStruct': {'date': '2009-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Systemic Aspergillosis', 'Systemic Candidiasis']}, 'descriptionModule': {'briefSummary': 'Pediatric patients are at high risk to acquire mycotic infections following allogeneic bone marrow transplantation. In the present retrospective analysis we assess the safety and efficacy of different regimens in antimycotic prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients undergoing allogeneic stem cell transplantation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients under the age of 18 years\n* Pediatric patients after HSCT treated with caspofungin\n* Pediatric patients after HSCT treated with liposomal amphotericin\n\nExclusion Criteria:\n\n* Pediatric patients with uncontrolled hematological malignancies\n* Pediatric patients with IFI at start of HSCT'}, 'identificationModule': {'nctId': 'NCT01040156', 'briefTitle': 'Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital Tuebingen"}, 'officialTitle': 'Safety, Feasibility and Efficacy of Caspofungin Versus Liposomal Amphotericin B as Antifungal Prophylaxis Following Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric Patients - a Retrospective Phase I/II Study', 'orgStudyIdInfo': {'id': 'UCHT-1209'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LAmb'}, {'label': 'Cas'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': "University Children's Hospital", 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Ingo Mueller, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCHT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital Tuebingen", 'class': 'OTHER'}}}}