Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-21 @ 6:23 AM
Study NCT ID:
NCT05422651
Status:
RECRUITING
Last Update Posted:
2022-06-29
First Post:
2022-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study About In-patients Admitted With Fever
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood includes blood cells and serum, urine and fecal samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of fever', 'timeFrame': '1 month after admission', 'description': 'The interval between the onset of fever and the return of body temperature to normal after medical intervention or spontaneous remission'}], 'secondaryOutcomes': [{'measure': 'Fever associated mortality', 'timeFrame': '3 months', 'description': 'mortality of patients due to conditions associated with fever'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fever']}, 'descriptionModule': {'briefSummary': 'Fever is a common symptom in patients with infectious diseases. This study hopes to understand the epidemiological characteristics of patients hospitalized due to fever through observational research, including: clinical characteristics, etiology of fever and prognosis after treatment. So as to further search for biochemical or other serological indicators to predict the diagnosis and prognosis of infectious fever and non-infectious fever, and try to establish relevant prediction models.', 'detailedDescription': 'This study mainly prospectively analyze the clinical data of patients with fever with/without other symptoms admitted to the department of infectious diseases, Xiangya Hospital of Central South University, to analyze the epidemiological characteristics, diagnosis and prognosis of these patients. This is an observational study. All subjects will receive the currently recognized routine test of fever according to their disease and corresponding etiological treatment if needed. The researchers will collect various clinical examination indexes of the subjects in the process of diagnosis and treatment, including but not limited to white blood cells, C-reactive protein, Procalcitonin, ferritin, blood culture, therapeutic drugs, etc. Etiology and prognosis of patients will be recorded. Blood samples, urine and stool samples of all subjects will be taken after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects. All subjects will sign informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between the age of 14-90, who were admitted to Department of Infectious Diseases because of fever with/without other symptoms were all elligible for this observational study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients admitted to department of infectious diseases because of fever\n\nExclusion Criteria:\n\n* patents who refuse to sign informed consent'}, 'identificationModule': {'nctId': 'NCT05422651', 'briefTitle': 'Observational Study About In-patients Admitted With Fever', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Characteristic, Diagnosis and Prognosis of Patients Admitted With Fever in Department of Infectious Diseases', 'orgStudyIdInfo': {'id': 'Xiangya fever project'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with fever', 'description': 'All subjects will receive the currently recognized routine test of fever according to their disease and corresponding etiological treatment if needed and no additional intervention and treatment will be added for subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Huang', 'role': 'CONTACT', 'email': 'ganrankedrhyan@163.com', 'phone': '+86 13874854142'}], 'facility': 'Department of Infectious Disease, Xiangya Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yan Huang', 'role': 'CONTACT', 'email': 'drhyan@163.com', 'phone': '13874854142'}], 'overallOfficials': [{'name': 'Yan Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiangya Hospital of Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Huang Yan', 'investigatorAffiliation': 'Xiangya Hospital of Central South University'}}}}