Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:23 PM
Study NCT ID:
NCT04535661
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2020-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 536}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-08-27', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'within 28 days after they discharged from PICU', 'description': 'The death rate of children in 28 days after their discharged from PICU'}], 'secondaryOutcomes': [{'measure': 'length of stay in PICU', 'timeFrame': 'within 28 days after they discharged from PICU', 'description': 'Time from PICU admission to discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carbapenem-Resistant Enterobacteriaceae Infection']}, 'descriptionModule': {'briefSummary': "Carbapenem-resistant Enterobacteriaceae (CRE) are increasingly identified in children in China. Pediatric intensive care unit (PICU) is the high-risk area. However, data on the epidemiology of CRE in hospitalized children in PICU are limited. The objectives of this study are to characterize the risk factors for colonization or infection with CRE and describe the microbiologic characteristics of pediatric CRE isolates. The investigators will perform a single retrospective study from January 2018 to December 2019 at PICU of Children's Hospital of Fudan University .", 'detailedDescription': "The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit PICU of Children's Hospital of Fudan University from January 2018 to December 2019. Children who had positive cultures for any Enterobacteriaceae species before their admission will be excluded. Children with a PICU length of day less than 48h will also be excluded. According to their clinical cultures results, they will be divided into non-CREćCRE colonization and CRE infection. CRE was defined according to the 2015 Centers for Disease Control and Prevention (CDC) definition as an isolate resistant to imipenem, meropenem, or ertapenem. Clinical and demographic data will be collected from the electronic health record."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '29 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019.\n\nExclusion Criteria:\n\n* discharge within 48 hours\n* patients had a positive culture for CRE before admission\n* incomplete clinical and demographic data"}, 'identificationModule': {'nctId': 'NCT04535661', 'briefTitle': 'Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'A Retrospective Single Center Study of the Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in PICU Hospitalized Children', 'orgStudyIdInfo': {'id': 'fdpicu-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non CRE', 'description': 'Children with a negative culture for CRE during their stay in PICU are defined as non CRE.'}, {'label': 'CRE colonization', 'description': 'Children who have a positive culture for CRE during their stay in PICU but lack of clinical symptoms are defined as CRE colonization.'}, {'label': 'CRE infection', 'description': 'Children who have a positive culture for CRE during their stay in PICU combined with clinical symptoms are defined as CRE infection.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoping Lu, MD', 'role': 'CONTACT', 'email': '13788904150@163.com', 'phone': '18017590817'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Gangfeng Yan', 'role': 'CONTACT', 'email': 'jinyi036@126.com', 'phone': '+8615900603082'}], 'overallOfficials': [{'name': 'Gangfeng Yan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fundan University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}