Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 1:54 AM
Study NCT ID:
NCT04923828
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2021-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chinese PICU Collaborative Network on Pathogens and Drug Resistance of Severe Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathogenic spectrum of PICU severe infection', 'timeFrame': '2016-2025', 'description': 'the 10 years of pathogenic spectrum of PICU severe infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PICU', 'pathogen', 'severs infection', 'drug resistance'], 'conditions': ['Severe Infection']}, 'descriptionModule': {'briefSummary': 'To investigate PICUs in major cities in China by establishing a high-quality standardized clinical database of PICU inpatients Incidence, fatality rate, pathogen distribution, anti-infective treatment of community-acquired/nosocomial infections in inpatients.', 'detailedDescription': "All patients admitted to the PICU during January 1, 2016 to December 31 2025 were included in the study, and all patients were followed up until death or PICU withdrawal. To establish the standardized Access database collected patients' general information, infection, PICU treatment, catheter, and short-term Prognosis and other clinical data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'PICU patients with severe infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PICU patients with severe infection\n\nExclusion Criteria:\n\n* Non-infected patient'}, 'identificationModule': {'nctId': 'NCT04923828', 'briefTitle': 'Chinese PICU Collaborative Network on Pathogens and Drug Resistance of Severe Infections', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': "Children's Hospital of Fudan University", 'orgStudyIdInfo': {'id': 'fdpicu-21'}}, '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': 'Guoping Lu, Doctor', 'role': 'CONTACT', 'email': '13788904150@163.com', 'phone': '13788904150'}, {'name': 'Jing Liu, Master', 'role': 'CONTACT', 'email': 'liujinggg@126.com', 'phone': '15800523953'}], 'overallOfficials': [{'name': 'Guoping Lu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guoping Lu', 'class': 'OTHER'}, 'collaborators': [{'name': "Shanghai Children's Hospital", 'class': 'OTHER'}, {'name': "Shanghai Children's Medical Center", 'class': 'OTHER'}, {'name': "Ningbo Women & Children's Hospital", 'class': 'OTHER'}, {'name': "Anhui Provincial Children's Hospital", 'class': 'OTHER'}, {'name': "Xian Children's Hospital", 'class': 'OTHER_GOV'}, {'name': "The Children's Hospital of Zhejiang University School of Medicine", 'class': 'OTHER'}, {'name': "Qilu Children's Hospital of Shandong University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of PICU', 'investigatorFullName': 'Guoping Lu', 'investigatorAffiliation': "Children's Hospital of Fudan University"}}}}