Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-28 @ 2:17 PM
Study NCT ID:
NCT06282835
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eravacycline Combination Therapy for MRAB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018410', 'term': 'Pneumonia, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571179', 'term': 'eravacycline'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2024-01-17', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Responded Rate', 'timeFrame': '28 days', 'description': "Complete the treatment, and meet one of the following criteria to be considered clinical respond: 1. Patient's oxygenation index is stable or improved; 2. Patients with a SOFA score \\<3 remain unchanged or decrease, and patients with a SOFA score ≥3 decrease by at least 30%; 3. Normal body temperature for more than 3 days; 4. Improvement in pulmonary imaging; 5. Infection indicators show a continuous downward trend for 3 consecutive day"}], 'secondaryOutcomes': [{'measure': 'The microbiological clearance rate', 'timeFrame': 'within 14days', 'description': 'The microbiological clearance rate at the end of treatment'}, {'measure': 'The all-cause mortality rate within 28 days', 'timeFrame': '28 days', 'description': 'The all-cause mortality rate within 28 days'}, {'measure': '"Incidence Rate of Adverse Event', 'timeFrame': '28days', 'description': 'safety data according to CTC-AE'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eravacyline'], 'conditions': ['Pulmonary Infection', 'Pneumonia, Bacterial', 'Acinetobacter Baumannii']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.\n\nParticipants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study plans to include patients diagnosed with CRAB pneumonia who seek medical attention at the Intensive Care Medicine Department of Fujian Medical University Union Hospital from January 2024 to April 2024', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ≥18 years old;\n2. Meets the diagnostic criteria for pneumonia specified by the Chinese Medical Association Respiratory Branch.\n3. CRAB is identified or predominant pathogenic bacteria, and drug sensitivity test indicates that Eravacycline is sensitive to the strain;\n4. Patients expected to receive Eravacycline for ≥4 days;\n5. Has already signed the informed consent\n\nExclusion Criteria:\n\n1. Pregnant or lactating;\n2. Concurrent intracranial infection, urinary tract infection, or bloodstream infection;\n3. Individuals in a moribund state;\n4. The investigator believes there is any medical history, current condition, treatment, laboratory abnormalities, or other circumstances that may affect the trial results, interrupt the trial process (or the subject's inability to complete all trial requirements, operations, and visits), or increase the subject's risk with the experimental medication. Patients with terminal illnesses or evidence of immediately life-threatening diseases are excluded;\n5. Patients with a history of allergic reactions to tetracyclines or any excipients in the investigational drug formulation"}, 'identificationModule': {'nctId': 'NCT06282835', 'briefTitle': 'Eravacycline Combination Therapy for MRAB', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University Union Hospital'}, 'officialTitle': 'The Effectiveness and Safety Study of Eravacycline Combination Therapy for Multidrug-Resistant Acinetobacter Baumannii Pneumonia', 'orgStudyIdInfo': {'id': '2023KY242'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Eravacyline combination', 'interventionNames': ['Drug: Eravacycline Injection']}], 'interventions': [{'name': 'Eravacycline Injection', 'type': 'DRUG', 'description': 'Eravacycline at the recommended dose and administration method according to the instructions: 1 mg/kg intravenous administration, every 12 hours. The intravenous infusion duration is approximately 60 minutes. For patients with severe liver impairment (Child-Pugh class C), administer 1 mg/kg of this product every 12 hours on the first day, followed by 1 mg/kg every 24 hours starting from the second day.', 'armGroupLabels': ['Eravacyline combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350000', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Zhang, Phd', 'role': 'CONTACT', 'email': 'xhzh@fjmu.edu.cn', 'phone': '13015723860'}], 'facility': 'Fujian Medical University Union hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Hui Zhang, PhD', 'role': 'CONTACT', 'email': 'xhzh@fjmu.edu.cn', 'phone': '+86 130 1572 3860'}], 'overallOfficials': [{'name': 'Hui Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Medical University Union Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Hui Zhang，PhD', 'investigatorAffiliation': 'Fujian Medical University Union Hospital'}}}}