Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT06121804
Status:
UNKNOWN
Last Update Posted:
2023-11-08
First Post:
2023-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunosuppressants to Postoperative Infection and Death
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007166', 'term': 'Immunosuppressive Agents'}], 'ancestors': [{'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2023-10-26', 'studyFirstSubmitQcDate': '2023-11-06', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative infection', 'timeFrame': 'From the date of underwent SOTs until the date of incident infection or date of death from any cause, whichever came first, assessed up to 5 years.', 'description': 'Postoperative infection contains Pneumocystis jiroveci pneumonia, cytomegalovirus disease, and Herpes simplex virus'}, {'measure': 'Death', 'timeFrame': 'From the date of underwent SOTs until the date of death from any cause, assessed up to 5 years.', 'description': 'Death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Organ Transplantation', 'Immunosuppressive Agents', 'Cohort Study']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://dep.mohw.gov.tw/DOS/cp-5119-59201-113.html', 'label': 'The Health and Welfare Data Science Center, Ministry of Health and Welfare Taiwan'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to explore the different immunosuppressive agents and related outcomes in organ transplantation patients in Taiwan. The main question it aims to answer is the risk of different immunosuppressive agents for infection and survival after transplant.\n\nThe study enrolled patients who underwent solid organ transplant (SOT), kidney (ICD-9-CM code V42.0), liver (ICD-9-CM code V42.7), or lung (ICD-9-CM code V42.6) transplants. We employed propensity score matching (PSM) to establish a matched cohort. The study will compare SOT patients and general patients to explore the risk of different immunosuppressive agents for infection and survival.', 'detailedDescription': "This study used secondary data from the Longitudinal Health Insurance Database (LHID), a subset of the NHIRD provided by the Health and Welfare Data Science Center (HWDC) of the Ministry of Health and Welfare in Taiwan.\n\nThe HWDC encrypts personally identifying data to protect the privacy of beneficiaries. The database includes detailed clinical records from both the inpatient and outpatient claims of the beneficiaries of Taiwan's National Health Insurance program. This program has provided coverage for up to 99% of the country's population since 1995. The NHIRD can serve as a foundation for the procurement of real-world evidence to support clinical decisions and health-care policy-making.\n\nDiagnostic data within the NHIRD from before 2016 and from 2016 or later are respectively coded using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes.\n\nThe database was provided by the HWDC under license and so cannot be made freely available. Requests for access to these data should be made to HWDC (https://dep.mohw.gov.tw/dos/cp-5119-59201-113.html)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The present study enrolled patients who underwent SOTs between 2002 and 2013, specifically, kidney (ICD-9-CM code V42.0), liver (ICD-9-CM code V42.7), or lung (ICD-9-CM code V42.6) transplants. Patients were excluded from our study if they received more than one SOT, had an infectious disease diagnosis before their SOT, or had incomplete medical information in the NHIRD.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent solid organ transplant (SOT)\n\nExclusion Criteria:\n\n* Patients who received more than one SOT, had an infectious disease diagnosis before their SOT or had incomplete medical information in the database.'}, 'identificationModule': {'nctId': 'NCT06121804', 'briefTitle': 'Immunosuppressants to Postoperative Infection and Death', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'The Cost-effectiveness Analysis of Immunosuppressants to Postoperative Infection and Death in the Patients With Organ Transplantation', 'orgStudyIdInfo': {'id': 'CS2-21134'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with organ transplantation', 'description': 'Patients who underwent SOTs between 2002 and 2013, specifically, kidney (ICD-9-CM code V42.0), liver (ICD-9-CM code V42.7), or lung (ICD-9-CM code V42.6) transplants.', 'interventionNames': ['Drug: Immunosuppressive Agents']}, {'label': 'Patients without organ transplantation', 'description': 'The general patients were enrolled as the comparison. We used propensity score matching (PSM) to establish a matched cohort.', 'interventionNames': ['Drug: Immunosuppressive Agents']}], 'interventions': [{'name': 'Immunosuppressive Agents', 'type': 'DRUG', 'description': 'Prescribing immunosuppressive agents', 'armGroupLabels': ['Patients with organ transplantation', 'Patients without organ transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40201', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chien-Ying Lee, PhD', 'role': 'CONTACT', 'email': 'cshd015@csmu.edu.tw', 'phone': '+886-4-24730022', 'phoneExt': '11664'}], 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Chien-Ying Lee, PhD', 'role': 'CONTACT', 'email': 'cshd015@csmu.edu.tw', 'phone': '886-4-24730022', 'phoneExt': '11664'}], 'overallOfficials': [{'name': 'Chien-Ying Lee, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chung Shan Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The database used to support the findings of this study was provided by the Health and Welfare Data Science Center, Ministry of Health and Welfare (HWDC, MOHW) Taiwan under license and so cannot be made freely available. Requests for access to these data should be made to HWDC (https://dep.mohw.gov.tw/dos/np-2497-113.html).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}