Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-29 @ 7:20 AM
Study NCT ID:
NCT04433403
Status:
UNKNOWN
Last Update Posted:
2021-09-22
First Post:
2020-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathogenic Microorganisms in Adult Severe Pneumonia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2020-06-13', 'studyFirstSubmitQcDate': '2020-06-13', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathogenic microorganism spectrum of adult severe pneumonia in Liaoning Province', 'timeFrame': '2020.7-2023.12', 'description': 'Detection of pathogenic microorganisms in severe pneumonia by second generation sequencing'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pathogenic Microorganism of Serious Pneumonia']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in different cities of Liaoning Province', 'detailedDescription': 'The pathogenic microorganisms of adult patients with severe pneumonia is detected in this study. Clinical treatment does not involve , so it meets the ethical requirements. The clinical data, laboratory test results and imaging data of adult severe pneumonia patients in different hospitals in different cities are recorded. The pathogenic microorganism is detected by second-generation sequencing of lower respiratory tract sputum or alveolar lavage fluid samples, and the data were sorted out to draw the pathogenic microorganism spectrum of adult severe pneumonia in Liaoning area. It will be used to guide clinical empirical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Severe pneumonia patients, aged 18 years and above, gender unlimited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the standard of severe pneumonia： Main standards： Requiring mechanical ventilation or septic shock requiring vasoconstrictor therapy.\n\nSecondary standards：(only if 3 items are met) Disturbance of consciousness; respiratory rate ≥ 30 times/min; PaO2/FiO2 ≤ 250, or PaO2 \\< 60mmHg; azotemia (BUN ≥ 7.12mmol / L); hypotension requires strong fluid resuscitation; infiltration of multiple lobes; leucopenia (WBC \\< 4 × 109 / L); thrombocytopenia (\\< 10 × 109 / L); hypothermia (T \\< 36 ℃).\n\nExclusion Criteria:\n\n* refuse to sign informed consent; inaccurate results due to unqualified sputum or BALF samples'}, 'identificationModule': {'nctId': 'NCT04433403', 'briefTitle': 'Pathogenic Microorganisms in Adult Severe Pneumonia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'A Multicenter Clinical Study on the Detection of Pathogenic Microorganisms in Adult Severe Pneumonia Patients in Liaoning Province', 'orgStudyIdInfo': {'id': 'PMASP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pathogenic microorganism', 'type': 'OTHER', 'description': 'Detection of pathogenic microorganisms in adult severe pneumonia by second generation sequencing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chaoyang Central Hospital', 'class': 'OTHER'}, {'name': 'Yingkou Central Hospital', 'class': 'UNKNOWN'}, {'name': 'Huludao central hospital', 'class': 'UNKNOWN'}, {'name': 'Dandong First Hospital', 'class': 'UNKNOWN'}, {'name': 'Fushun Mining Bureau General Hospital', 'class': 'UNKNOWN'}, {'name': 'Benxi Cental Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'deputy director of emergency department', 'investigatorFullName': 'Hongyu Zhao', 'investigatorAffiliation': 'Shengjing Hospital'}}}}