Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-30 @ 7:52 PM
Study NCT ID:
NCT04310657
Status:
UNKNOWN
Last Update Posted:
2020-03-17
First Post:
2020-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
mNGS Was Applied to the Study of Pathogen Identification, Precision Medication and Efficacy Evaluation of Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2020-03-13', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28 days', 'description': '28-day mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['mNGS']}, 'descriptionModule': {'briefSummary': '1\\) prospectively collected the patients with the proposed infection, confirmed the infection or excluded the infection through mNGS detection combined with traditional pathogen detection methods and clinical characteristics, compared the detection performance of mNGS and traditional methods, and explored the significance of mNGS microbial map characteristics for the diagnosis/exclusion of infection; 2) real-time dynamic monitoring of the pathogen and microecology of infected patients during the targeted drug use, and evaluation of the efficacy in combination with other indicators; 3) to explore the significance of the number of pathogen sequences before the clinical withdrawal of drugs to the clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 75 years old\n* expected length of stay in ICU was \\> 24 h\n* suspected infected patients (PSI or CPIS, qSOFA or SIRS)\n\nExclusion Criteria:\n\n* Pregnant and lactating women\n* Who has not signed the informed consent\n* the researchers considered that others were not suitable for the study'}, 'identificationModule': {'nctId': 'NCT04310657', 'briefTitle': 'mNGS Was Applied to the Study of Pathogen Identification, Precision Medication and Efficacy Evaluation of Infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'mNGS Was Applied to the Study of Pathogen Identification, Precision Medication and Efficacy Evaluation of Infected Patients', 'orgStudyIdInfo': {'id': 'mNGS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Precision therapy', 'interventionNames': ['Diagnostic Test: mNGS']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'mNGS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Metagenomics second generation sequencing technology', 'armGroupLabels': ['Precision therapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof', 'investigatorFullName': 'Ruilan Wang', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}