Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-31 @ 3:40 AM
Study NCT ID:
NCT04045366
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2019-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood and BAL (bronchoalveolar lavage)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2019-06-14', 'studyFirstSubmitQcDate': '2019-08-02', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve (AUC)', 'timeFrame': 'July 2020', 'description': 'The area under the concentration-time curve will be calculated'}, {'measure': 'Half-life (T1/2)', 'timeFrame': 'July 2020', 'description': 'The half-life will be calculated'}, {'measure': 'Volume of distribution (Vd)', 'timeFrame': 'July 2020', 'description': 'The volume of distribution will be calculated'}, {'measure': 'Clearance (CL)', 'timeFrame': 'July 2020', 'description': 'The clearance will be calculated'}, {'measure': 'Maximum plasma concentration', 'timeFrame': 'July 2020', 'description': 'The median maximum plasma concentration will be reported'}, {'measure': 'Minimum plasma concentration', 'timeFrame': 'July 2020', 'description': 'The median minimum plasma concentration will be reported'}, {'measure': 'Average plasma concentration', 'timeFrame': 'July 2020', 'description': 'The average plasma concentration will be calculated'}], 'secondaryOutcomes': [{'measure': 'Influence of serum creatinin (mg/dL) on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of glomerular filtration rate (ml/min) on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of on bilirubin on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of gamma-GT on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of alkaline phosphatase on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of AST on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of ALT on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of total protein on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of serum albumin on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of Ang-1 on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of Ang-2 on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of VEGF on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of inflammation (CRP) on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of fluid balance (mL) on echinocandin-exposure', 'timeFrame': 'July 2020'}, {'measure': 'Influence of prothrombin time on echinocandin-exposure', 'timeFrame': 'July 2020'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Echinocandins', 'Critically ill patients'], 'conditions': ['Critically Ill Patients']}, 'descriptionModule': {'briefSummary': 'This prospective study will explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.', 'detailedDescription': 'This non-randomized, monocenter pharmacokinetic study will be carried out in critically ill patients receiving multiple dose treatment with echinocandins (caspofungin or anidulafungin).\n\nThe pharmacokinetics and pharmacodynamics of the echinocandins in plasma and BAL will be determined. Especially, the relative contributions of two pathophysiological alterations (capillary leak and hypoalbuminemia) encountered in critically ill patients, will be explored.\n\nAlso other correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment with anidulafungin or caspofungin\n* Admitted to an ICU ward\n\nExclusion Criteria:\n\n* \\< 18 years\n* DNR 2 or 3'}, 'identificationModule': {'nctId': 'NCT04045366', 'briefTitle': 'Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'S54510'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sample collection', 'type': 'OTHER', 'description': 'Plasma and BAL sample collection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Isabel Spriet, PharmD, PhD', 'role': 'CONTACT', 'email': 'isabel.spriet@uzleuven.be', 'phone': '+32 16 34 30 80'}, {'name': 'Ruth Van Daele, PharmD', 'role': 'CONTACT', 'email': 'ruth.vandaele@uzleuven.be', 'phone': '+32 16 34 30 80'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Isabel Spriet, PharmD, PhD', 'role': 'CONTACT', 'email': 'isabel.spriet@uzleuven.be', 'phone': '+32 16 34 30 80'}, {'name': 'Ruth Van Daele, PharmD', 'role': 'CONTACT', 'email': 'ruth.vandaele@uzleuven.be', 'phone': '+32 16 34 30 80'}], 'overallOfficials': [{'name': 'Isabel Spriet, PharmD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'KU Leuven', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}