Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT04937894
Status:
UNKNOWN
Last Update Posted:
2021-06-24
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Therapy for Infectious Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078304', 'term': 'Tigecycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-23', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Through study completion, an average of 15 days', 'description': 'Drug-related adverse events and serious adverse events'}, {'measure': 'Pharmacokinetics of tigecycline', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'clearance in L/h'}, {'measure': 'Rate constant for tigecycline distribution', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'Pharmacokinetics of tigecycline'}, {'measure': 'The ratio of area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC).', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'PD target'}], 'secondaryOutcomes': [{'measure': 'fibrinogen levels in mg/dL', 'timeFrame': 'Through study completion, an average of 3 days'}, {'measure': 'prothrombin time', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'prothrombin time in second'}, {'measure': 'activated partial thromboplastin time', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'activated partial thromboplastin time in second'}, {'measure': 'international normalized ratio', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'international normalized ratio，INR'}, {'measure': 'blood platelet count', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'blood platelet count in ×10\\^9/L'}, {'measure': 'thrombin time', 'timeFrame': 'Through study completion, an average of 3 days', 'description': 'thrombin time in second'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infectious Disease']}, 'descriptionModule': {'briefSummary': 'Tigecycline is a last-resort antibiotic that is used to treat severe infections caused by extensively drug-resistant bacteria. However, the efficacy and safety data for tigecycline in infectious patients are lacking. The aim of this study is to assess the efficacy and safety of tigecycline in infectious patients using pharmacokinetics and omics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with severe infections', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* critically ill hospitalized males or nonpregnant females aged 18 years with severe infections which the treating clinician was treating with tigecycline\n\nExclusion Criteria:\n\n1. severe liver dis- eases (e.g., Child-Pugh score C);\n2. patients allergic to tetracycline and tigecycline;\n3. those who have participated in other clinical trials, or those who are considered unsuitable by researchers;\n4. pregnant women and lactating women.'}, 'identificationModule': {'nctId': 'NCT04937894', 'briefTitle': 'Antibiotic Therapy for Infectious Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'The Efficacy and Safety of Tigecycline for the Treatment of Infectious Diseases', 'orgStudyIdInfo': {'id': '2021_TIG_001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tigecycline', 'type': 'DRUG', 'description': 'Efficacy and safety of Tigecycline'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Zhao, Ph.D', 'role': 'CONTACT', 'email': 'zhao4wei2@hotmail.com', 'phone': '86053188383308'}], 'facility': 'Wei Zhao', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Wei Zhao, Ph.D', 'role': 'CONTACT', 'email': 'zhao4wei2@hotmail.com', 'phone': '86053188383308'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department of clinical pharmacy and pharmacology', 'investigatorFullName': 'Wei Zhao', 'investigatorAffiliation': 'Shandong University'}}}}