Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT05767294
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-22
First Post:
2023-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-03-01', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with fever', 'timeFrame': 'at admission', 'description': 'number of patients with fever'}, {'measure': 'number of patients with cough', 'timeFrame': 'at admission', 'description': 'number of patients with cough'}, {'measure': 'number of patients with shortness of breath', 'timeFrame': 'at admission', 'description': 'number of patients with shortness of breath'}, {'measure': 'number of patients with shortness of wheeze', 'timeFrame': 'at admission', 'description': 'number of patients with shortness of wheeze'}, {'measure': 'number of patients with shortness of vomit', 'timeFrame': 'at admission', 'description': 'number of patients with shortness of vomit'}, {'measure': 'number of patients with shortness of rale', 'timeFrame': 'at admission', 'description': 'number of patients with shortness of rale'}, {'measure': 'number of patients with shortness of stridor', 'timeFrame': 'at admission', 'description': 'number of patients with shortness of stridor'}, {'measure': 'age', 'timeFrame': 'at admission', 'description': 'age'}, {'measure': 'gender', 'timeFrame': 'at admission', 'description': 'female/male'}, {'measure': 'number of patients with underlying disease', 'timeFrame': 'at admission', 'description': 'underlying disease include immune deficiency, CHD, BPD, BO, bronchiectasis and asthma and so on'}, {'measure': 'Imaging examination results', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'X-Ray/CT'}, {'measure': 'length of hospital stay length of stay length of stay', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'length of hospital stay'}, {'measure': 'number of patients with treatment of antibiotic', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of patients with treatment of antibiotic'}, {'measure': 'number of patients with treatment of immunoglobulin', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of patients with treatment of immunoglobulin'}, {'measure': 'number of patients with treatment of glucocorticoids', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of patients with treatment of glucocorticoids'}, {'measure': 'number of patients with treatment of oxygen inhalation', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of patients with treatment of oxygen inhalation'}, {'measure': 'number of patients with treatment of ventilation', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of patients with treatment of ventilation'}, {'measure': 'direct medical cost', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'direct medical cost'}, {'measure': 'proportion of different virus genotype', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'virus genotype include A, B and C'}, {'measure': 'F protein gene sequence', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'F protein gene sequence'}, {'measure': 'number of patients infected with bacteria', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of patients infected with bacteria'}, {'measure': 'number of patients infected with virus', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of patients infected with virus'}, {'measure': 'number of patients infected with fungus', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of patients infected with fungus'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['RSV Infection']}, 'descriptionModule': {'briefSummary': 'The study will be a multicenter, hospital-based retrospective study. We plan to collect the clinical and laboratory data among all hospitalized ARTI cases in three hospitals in Wuhan from June 1, 2020 to May 31, 2023 and then analyze the epidemiological and clinical characteristics of RSV infection, clarify the gene types of epidemics under 5 years old children after the outbreak in Wuhan, China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all hospitalized ARTI cases in three hospitals in Wuhan from June 1, 2020 to May 31, 2023 and then analyze the epidemiological and clinical characteristics of RSV infection, clarify the gene types of epidemics under 5 years old children after the outbreak in Wuhan, China', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n①Admission age \\<5 years old\n\n②Clinical diagnosis of acute respiratory tract infections\n\nExclusion Criteria:\n\nHospital acquired ARTI'}, 'identificationModule': {'nctId': 'NCT05767294', 'briefTitle': 'Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Epidemiological and Clinical Characteristics of Hospitalized Patients Under 5 Years Old With RSV Infection in Central China, Wuhan', 'orgStudyIdInfo': {'id': 'MISP-100898'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neonatal', 'interventionNames': ['Other: Observation']}, {'label': '1-3 months old', 'interventionNames': ['Other: Observation']}, {'label': '3-6 months old', 'interventionNames': ['Other: Observation']}, {'label': '6 months-1 year old', 'interventionNames': ['Other: Observation']}, {'label': '1-2 years old', 'interventionNames': ['Other: Observation']}, {'label': '2-5 years old', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'clinical manifestation (body temperature, fever days before admission, cough, red throat/sore throat, runny nose, shortness of breath, wheezing, vomiting), physical signs (auscultation of lungs, X-ray results), length of stay, therapeutic measures (oxygen therapy, ICU admission, antibiotic therapy, etc.)', 'armGroupLabels': ['1-2 years old', '1-3 months old', '2-5 years old', '3-6 months old', '6 months-1 year old', 'Neonatal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'department of pediatrics, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Tongji Hospital, Tongji Medical college, Huazhong University of Science & Technology', 'investigatorFullName': 'Sainan Shu', 'investigatorAffiliation': 'Tongji Hospital'}}}}