Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT00704951
Status:
WITHDRAWN
Last Update Posted:
2015-08-25
First Post:
2008-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101425', 'term': 'posaconazole'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2008-06-23', 'studyFirstSubmitQcDate': '2008-06-23', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: adverse events', 'timeFrame': 'Depending on treatment modality every 2 to 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Baseline: Patient demographic data; Disease history; Underlying diseases; Diagnosis; Previous therapies; Environmental risk factors; Host factors Performance status', 'timeFrame': 'Depending on treatment modality every 2 to 4 weeks'}, {'measure': 'Treatment and follow up period: Performance status; Medication; Duration of treatment; Frequency of infectious episodes; Management of infections', 'timeFrame': 'Depending on treatment modality every 2 to 4 weeks'}, {'measure': 'Adverse events; Survival status', 'timeFrame': 'Depending on treatment modality every 2 to 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mycoses']}, 'descriptionModule': {'briefSummary': 'The purpose of this program is to determine the frequency of the use of Posaconazole in immunocompromised patients refractory to first line therapy receiving therapeutic treatment based on different pathogens in comparison to other antifungal therapy.\n\nA further objective is to determine the frequency of the use of Posaconazole in immunocompromised patients receiving prophylactic treatment in comparison to other antifungal prophylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Immunocompromised patients with refractory IFI\n* Patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00704951', 'briefTitle': 'Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'P05532 Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections (IFIs) in Immuncompromised Patients in Austria. Version 1, 08-Nov-2007.', 'orgStudyIdInfo': {'id': 'P05532'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections', 'interventionNames': ['Drug: Posaconazole or alternative fungal treatment']}], 'interventions': [{'name': 'Posaconazole or alternative fungal treatment', 'type': 'DRUG', 'description': 'Dosage of Posaconazole:\n\nProphylactic dosing: 200mg tid (600mg/day) Treatment dosing: 400mg bid (800mg/day)', 'armGroupLabels': ['Patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}