Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04413305
Status:
UNKNOWN
Last Update Posted:
2020-06-02
First Post:
2020-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
WGS-guided Tracking and Infection Control Measures of CRKP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2020-05-28', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the influence of WGS-based screen and control measures on the CRKP occurrence rate', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Analysis of transmission pattern and route pre and post WGS-based tracking', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Klebsiella Pneumoniae Infection']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the effect of the infection control measures based on the active screening of carbapenem-resistant Klebsiella pneumoniae and whole-genome based tracking and surveillance though the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient was admitted to the ICU of neurosurgery in the west hospital of huashan hospital affiliated to fudan university from September 2019 to September 2021, or transferred from the ICU of another hospital\n2. The patient is more than 18 years old and less than 80 years old, regardless of gender.\n3. Informed consent of the patient;\n\nExclusion Criteria:\n\n1. Patients participating in other clinical trials at the same time\n2. Pregnant\n\n4\\. People who will affect the outcome of the study: whose specimens could not be received or not enough for testing'}, 'identificationModule': {'nctId': 'NCT04413305', 'briefTitle': 'WGS-guided Tracking and Infection Control Measures of CRKP', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'WGS-guided Tracking and Infection Control Measures of Carbapenem-resistant Klebsiella Pneumoniae', 'orgStudyIdInfo': {'id': 'KY2019-429KP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WGS-based screen and control group', 'description': "For intervention group, we screen admitted patients for carbapenem-resistant Klebsiella pneumoniae and carry out 'Bundle' infection and control measures. When outbreak or tranmission of CRKP was observed, we take whole-genome sequencing to track origin and transmission route to decease CRKP rate.", 'interventionNames': ['Other: screen of CRKP and infection control measure']}, {'type': 'NO_INTERVENTION', 'label': 'Non-intervention', 'description': 'Non-intervention'}], 'interventions': [{'name': 'screen of CRKP and infection control measure', 'type': 'OTHER', 'description': "For intervention group, we screen admitted patients for carbapenem-resistant Klebsiella pneumoniae and carry out 'Bundle' infection and control measures. When outbreak or tranmission of CRKP was observed, we take whole-genome sequencing to track origin and transmission route to decease CRKP rate.", 'armGroupLabels': ['WGS-based screen and control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenhong Zhang', 'role': 'CONTACT', 'email': 'zhangwenhong@fudan.edu.cn', 'phone': '(86)52889999'}], 'facility': 'Infectious department of Huashan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sumitomo Pharmaceuticals (Suzhou) Co. Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wen-hong Zhang', 'investigatorAffiliation': 'Huashan Hospital'}}}}