Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 1:19 PM
Study NCT ID:
NCT07080359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isavuconazole in Critically Ill Patients: Efficacy and Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D009091', 'term': 'Mucormycosis'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020096', 'term': 'Zygomycosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological Progress in Pulmonary Fungal Infections', 'timeFrame': 'At treatment day 42', 'description': 'A chest CT uses X-ray tomography, where the patient lies on a table while the machine rotates to capture cross-sectional images'}, {'measure': 'Plasma concentration', 'timeFrame': 'On or after day 7 post-dose', 'description': 'Venous blood samples were collected, centrifuged to obtain supernatant, and concentrations were measured by liquid chromatography-tandem mass spectrometry'}, {'measure': 'Change in immune function profiles (cellular and humoral immunity markers)', 'timeFrame': 'Enrollment (Baseline) → Treatment Day 42', 'description': 'Specific immune markers (e.g., CD4+/CD8+ counts, immunoglobulin levels, or cytokine profiles) will be selected based on emerging evidence or preliminary data prior to finalizing the statistical analysis plan.'}, {'measure': 'Composite infection biomarker profile (including PCT, CRP, IL-6 and WBC)', 'timeFrame': 'Enrollment (Baseline) → Treatment Day 42', 'description': 'The assessment of infection progression is conducted through a comprehensive scoring system as follows:\n\nInfection Biomarker Score (0-8 points) based on:\n\n* PCT \\>0.5 ng/mL (2 point)\n* CRP \\>10 mg/L (1 point)\n* IL-6 \\>30 pg/mL (2 point)\n* WBC \\>10×10⁹/L (3 point)'}], 'secondaryOutcomes': [{'measure': 'Electrocardiogram QT Interval', 'timeFrame': 'On day 10 post-dose', 'description': 'A 6-lead ECG was performed.'}, {'measure': 'Composite liver function outcome (including ALT, AST, bilirubin, ALP, and albumin).', 'timeFrame': 'From enrollment (Day 0) through Treatment Day 42', 'description': 'Hepatic function will be assessed using a composite scoring system (0-10 points) incorporating:\n\nALT elevation \\>3×ULN (2 points) AST elevation \\>3×ULN (2 points) Total bilirubin \\>2×ULN (3 points)\n\n* ALP \\>2×ULN (2 points)\n* Albumin \\<3.0 g/dL (1 point)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fungal Infection', 'Aspergillosis', 'Mucormycosis']}, 'descriptionModule': {'briefSummary': 'Due to factors such as disease status, gastrointestinal conditions, commonly used medications (e.g., vasopressors), and cardiac output, the plasma concentration of isavuconazole in critically ill patients may differ from that in healthy individuals, exhibiting significant variability.\n\nThis study aims to explore the variability of isavuconazole plasma concentrations in critically ill patients and its correlation with efficacy and adverse effects. The research includes:\n\n1. The distribution and variability of isavuconazole plasma concentrations in critically ill patients;\n2. Clinical outcomes;\n3. Adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult ICU patients meeting criteria for isavuconazole therapy according to the '2023 Isavuconazole Clinical Expert Consensus'", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult critically ill patients (≥18 years) admitted to ICU with suspected or confirmed invasive fungal infection (IFI)\n* IFI diagnosis per EORTC/MSGERC 2019 criteria\n\nExclusion Criteria:\n\n* Drug allergy\n* Inherited short QT syndrome\n* Contraindications for nasogastric/oral drug delivery\n* \\<18 years old'}, 'identificationModule': {'nctId': 'NCT07080359', 'briefTitle': 'Isavuconazole in Critically Ill Patients: Efficacy and Safety', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Isavuconazole in Critically Ill Patients: A Study on Antifungal Efficacy and Safety', 'orgStudyIdInfo': {'id': 'SHSY-IEC-6.0/25K114/P01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Isavuconazole group', 'description': 'Critically ill patients who meet the indicated conditions per the prescribing information, administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)', 'interventionNames': ['Drug: Isavuconazole treatment']}], 'interventions': [{'name': 'Isavuconazole treatment', 'type': 'DRUG', 'description': 'Administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)', 'armGroupLabels': ['Isavuconazole group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wen-Xiang Cao', 'role': 'CONTACT', 'email': '731438603@qq.com', 'phone': '+8613062772669'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions", 'accessCriteria': "Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Clinical Pharmacist', 'investigatorFullName': 'Wen-Xiang Cao', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}