Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-11 @ 1:01 PM
Study NCT ID:
NCT06190002
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics and Risk Factors for Invasive Fungal Infection With Acute-on-chronic Hepatitis B Liver Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-02', 'studyFirstSubmitDate': '2023-12-17', 'studyFirstSubmitQcDate': '2024-01-02', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with invasive fungal infection', 'timeFrame': 'January 2010 to July 2023', 'description': 'Invasive candidiasis: isolation of Candida in one or more blood cultures (candidemia) or from normal sterile body fluids. Candida colonization: Candida was isolated in non-sterile fluid without infection. Probable invasive aspergillosis: Detection of Aspergillus by direct examination and/or culture of respiratory specimens under imaging that is consistent with the presence of pulmonary infection. Probable invasive fungal infection(IFI) was defined as the presence of clinical features including lower respiratory tract mycosis (nodules, halo sign, air crescent sign, or cavity on chest CT scan) and a positive aspergillus culture in sputum specimen. In fact, the definitions of probable IFI and IFI are the same, except that probable IFI lacks mycological evidence.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute-on-chronic Hepatitis B Liver Failure']}, 'referencesModule': {'references': [{'pmid': '18462102', 'type': 'BACKGROUND', 'citation': 'De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, Pappas PG, Maertens J, Lortholary O, Kauffman CA, Denning DW, Patterson TF, Maschmeyer G, Bille J, Dismukes WE, Herbrecht R, Hope WW, Kibbler CC, Kullberg BJ, Marr KA, Munoz P, Odds FC, Perfect JR, Restrepo A, Ruhnke M, Segal BH, Sobel JD, Sorrell TC, Viscoli C, Wingard JR, Zaoutis T, Bennett JE; European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group; National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clin Infect Dis. 2008 Jun 15;46(12):1813-21. doi: 10.1086/588660.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-center retrospective study. The clinical data of patients with Acute-on-chronic Hepatitis B liver failure who were hospitalized in the Department of Hepatology, Qilu Hospital of Shandong University from January 2010 to July 2023 were collected.', 'detailedDescription': 'The clinical data of patients with Acute-on-chronic Hepatitis B liver failure who were hospitalized in the Department of Hepatology, Qilu Hospital of Shandong University from January 2010 to July 2023 were collected, including age, gender, HBsAg,HBeAg, serum hepatitis B virus DNA, alanine aminotransferase, aspartate aminotransferase, Platelet, white blood cell,neutrophilic granulocyte percentage, neutrophile granulocyte, total bilirubin, creatinine, international normalized ratio,procalcitonin,globulin. prothrombin time activity, 1, 3 - beta glucan D test, Galactomannan test, sputum culture, imaging CT and other indicators. Our study followed up patients with Acute-on-chronic Hepatitis B liver failure with fungal infection during hospitalization to clarify the clinical characteristics and risk factors of fungal infection in the development of Acute-on-chronic Hepatitis B liver failure , and to provide clinical prevention and treatment recommendations for fungal infection in patients with Acute-on-chronic Hepatitis B liver failure . Thus, the prognosis of patients can be improved and the survival rate can be increased.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The clinical data of patients with Acute-on-chronic hepatitis B liver failure hospitalized in the Department of Hepatology, Qilu Hospital of Shandong University from January 2010 to July 2023 were retrospectively collected. According to the inclusion criteria, 244 patients were finally included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute liver function injury TBIL≥5mg/dl(85umol/L) and international normalized ratio (INR) ≥1.5 or PTA≤40% based on previously known chronic hepatitis B or compensated cirrhosis.\n* Combined with ascites and/or hepatic encephalopathy within 4 weeks.\n* HBsAg（+)\\>6 months\n\nExclusion Criteria:\n\n* Patients died within 48 hours of admission or withdrew treatment.\n* Combined with liver cancer and other extrahepatic organ malignant tumors, rheumatic diseases, hyperthyroidism.\n* Age \\<18 years old.'}, 'identificationModule': {'nctId': 'NCT06190002', 'briefTitle': 'Characteristics and Risk Factors for Invasive Fungal Infection With Acute-on-chronic Hepatitis B Liver Failure', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Characteristics and Risk Factors for Invasive Fungal Infection in Hospitalized Patients With Acute-on-chronic Hepatitis B Liver Failure: A Retrospective Cohort Study From 2010 to 2023', 'orgStudyIdInfo': {'id': 'KYLL-202310-035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'invasive fungal infection group and non-invasive fungal infection group', 'description': 'According to the presence or absence of invasive fungal infection, the patients were divided into invasive fungal infection group and non-invasive fungal infection group'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yu-Chen Fan, MD,PhD', 'role': 'CONTACT', 'email': 'fanyuchen@sdu.edu.cn', 'phone': '18560082065'}], 'overallOfficials': [{'name': 'Yu-Chen Fan, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}