Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-27 @ 2:09 AM
Study NCT ID:
NCT01047267
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2010-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058365', 'term': 'Candidiasis, Invasive'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-05', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the correlation of pharmacokinetic parameters of anidulafungin with markers for disease severity - either disease severity scores or parameters (singly, or combined) for inflammation or organ function - and plasma protein levels.', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'Time (in days) to culture conversion', 'timeFrame': 'max 28 days'}, {'measure': 'Response to treatment at day 28', 'timeFrame': '28 days'}, {'measure': 'Mortality at day 28 due to fungal infection and overall mortality at 28 days', 'timeFrame': '28 days'}, {'measure': 'AUC/MIC ratio, time above MIC', 'timeFrame': 'max 28 days'}, {'measure': 'Composing a pharmacokinetic model of anidulafungin in critically ill patients', 'timeFrame': 'max 28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['candidiasis', 'invasive fungal disease', 'critically ill', 'anidulafungin', 'pharmacokinetics'], 'conditions': ['Invasive Candidiasis', 'Critically Ill']}, 'referencesModule': {'references': [{'pmid': '25487797', 'type': 'DERIVED', 'citation': 'van Wanrooy MJ, Proost JH, Rodgers MG, Zijlstra JG, Uges DR, Kosterink JG, van der Werf TS, Alffenaar JW. Limited-sampling strategies for anidulafungin in critically ill patients. Antimicrob Agents Chemother. 2015 Feb;59(2):1177-81. doi: 10.1128/AAC.03375-14. Epub 2014 Dec 8.'}, {'pmid': '24165173', 'type': 'DERIVED', 'citation': 'van Wanrooy MJ, Rodgers MG, Uges DR, Arends JP, Zijlstra JG, van der Werf TS, Kosterink JG, Alffenaar JW. Low but sufficient anidulafungin exposure in critically ill patients. Antimicrob Agents Chemother. 2014;58(1):304-8. doi: 10.1128/AAC.01607-13. Epub 2013 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.', 'detailedDescription': 'One of the risk factors for mortality of patients with candidemia is inadequate antifungal therapy. The first days in the intensive care unit (ICU), patients are unstable and it can be questioned whether therapeutic levels of anidulafungin are reached after a standard loading scheme. At this moment there are several clues that the PK of anidulafungin in critically ill patients is different, but an overall picture is lacking.\n\nFor the investigation of the correlation of the pharmacokinetics of anidulafungin and the disease severity a full pharmacokinetic profile will be obtained. Predictive scoring systems will be used to assess disease severity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with invasive candidiasis admitted to an intensive care unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* treatment with anidulafungin\n* at least 18 years of age\n* invasive candidiasis\n* admitted to an intensive care unit\n\nExclusion Criteria:\n\n* allergic to anidulafungin or its excipients\n* contra-indication stated in SPC\n* neutropenia'}, 'identificationModule': {'nctId': 'NCT01047267', 'briefTitle': 'Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Pharmacokinetics of Anidulafungin in Critically Ill Patients With Invasive Candidiasis', 'orgStudyIdInfo': {'id': 'ANIDULA-133'}}, 'contactsLocationsModule': {'locations': [{'zip': '9713GZ', 'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'JWC Alffenaar, PharmD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Center Groningen'}, {'name': 'MJP van Wanrooy, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PharmD, PhD', 'investigatorFullName': 'JWC Alffenaar', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}