Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:53 AM
Study NCT ID:
NCT05698160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-19
First Post:
2023-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2023-01-16', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarkers associated with the coagulation dysfunction induced tigecycline', 'timeFrame': 'January 2023-December 2025', 'description': 'Multi-omics will be adopted to screen out biomarkers associated with the coagulation dysfunction induced by tigecycline.'}], 'secondaryOutcomes': [{'measure': 'Prediction model for coagulation dysfunction induced by tigecycline', 'timeFrame': 'January 2023-December 2025', 'description': 'Machine learning techbology will be adopted to establish the prediction model for coagulation dysfunction induced by tigecycline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tigecycline', 'Blood Coagulation Disorder', 'multi-omics', 'machine learning techbology'], 'conditions': ['Blood Coagulation Disorder']}, 'descriptionModule': {'briefSummary': 'This study is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline', 'detailedDescription': 'The critically ill patients treated with tigecycline in in tensive care unit will be recruited and divided into tigecycline-induced coagulation dysfunction group and non-coagulation dysfunction group. The multi-omics will be used to screen out biomarkers for early prediction of coagulation dysfunction caused by tigecycline. Afterwards, machine learning methods will be adopted to establish the the early prediction model of tigecycline-induced coagulation dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The critically ill patients treated with tigecycline in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients receiving tigecycline treatment in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School\n* Intravenous tigecycline ≥ 3 days\n* Monitoring the plasma concentration of tigecycline\n\nExclusion Criteria:\n\n* Missing clinical data'}, 'identificationModule': {'nctId': 'NCT05698160', 'briefTitle': 'Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction Based on Multi-omics and Machine Learning Techbology', 'orgStudyIdInfo': {'id': '2022-LCYJ-PY-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coagulation dysfunction group', 'description': 'The critically ill patients in intensive care unit showed coagulation dysfunction after treated with tigecycline.'}, {'label': 'non-coagulation dysfunction group', 'description': 'The critically ill patients in intensive care unit showed normal coagulation function after treated with tigecycline.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}