Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-05 @ 5:27 PM
Study NCT ID:
NCT03399032
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2018-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Caspofungin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077336', 'term': 'Caspofungin'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], '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'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Patients' arterial blood samples."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2018-01-07', 'studyFirstSubmitQcDate': '2018-01-07', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentration of caspofungin', 'timeFrame': '72 hours for each patient from the tigecycline treatment initiation', 'description': 'Samples obtain from ICU patients 2, 4, 8 12 and 24hours after each dose of caspofungin for 3 days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['caspofungin', 'pharmacokinetics'], 'conditions': ['Septic Shock', 'Fungal Infection', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '32601169', 'type': 'DERIVED', 'citation': 'Borsuk-De Moor A, Sysiak-Slawecka J, Rypulak E, Borys M, Piwowarczyk P, Raszewski G, Onichimowski D, Czuczwar M, Wiczling P. Nonstationary Pharmacokinetics of Caspofungin in ICU Patients. Antimicrob Agents Chemother. 2020 Aug 20;64(9):e00345-20. doi: 10.1128/AAC.00345-20. Print 2020 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients.', 'detailedDescription': "This is a prospective observational study performed on critically ill patients. Inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical and surgical patients will be included. Any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes: broad spectrum anti-bacterial antibiotics plus caspofungin (70 mg i.v. on the first day day, and 50 mg i.v. on the consecutive days, once daily.\n\nBlood samples (3 mL) will be collected 2, 4, 8,12 and 24 hours after each dose of caspofungin for 3 consecutive days. The standard arterial canula will be used to obtain samples.\n\n30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.\n\nSerum caspofungin concentration will be measured with high performance liquid chromatography.\n\nEach patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to ICU due to severer sepsis recognition. Both medical and surgical patients will be included. Any site of infection will be treated in the manner.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who require ICU treatment due to severe sepsis age\n* 18-80 years\n* an eligible consent obtained from the patient or his/her attendant\n\nExclusion Criteria:\n\n* allergy to caspofungin\n* lack of consent to participate in the study\n* age of patients below 18 or above 80 years'}, 'identificationModule': {'nctId': 'NCT03399032', 'briefTitle': 'Pharmacokinetics of Caspofungin', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lublin'}, 'officialTitle': 'Pharmacokinetics of Caspofungin in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'KE-0254/330/2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caspofungin', 'description': 'Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day', 'interventionNames': ['Drug: Caspofungin']}], 'interventions': [{'name': 'Caspofungin', 'type': 'DRUG', 'otherNames': ['blood collection'], 'description': 'Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day\n\nBlood samples (3 mL) will be collected 2, 4, 8, 12 and 24 hours after each dose of caspofungin for 3 consecutive days.', 'armGroupLabels': ['Caspofungin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20-081', 'city': 'Lublin', 'country': 'Poland', 'facility': 'II Department of Anesthesia and Intensive Care, Medical University of Lublin', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lublin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Michał Borys', 'investigatorAffiliation': 'Medical University of Lublin'}}}}