Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05374018
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2022-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urinary Antigen Test for Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of strep pneumonia', 'timeFrame': '2 years', 'description': 'to determine prevalence'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'This is an epidemiology study for the prevalence and serotypes of pneumococcus pneumoniae in hospitalized patients with community acquired pneumonia (CAP). The serotypes of the pneumococcus pneumoniae will be determined by a urinary antigen assay'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted for CAP', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdmitted with signs and symptoms suggestive of pneumonia which include one or more of the followings:\n\n1. fever\n2. CXR changes with consolidation, increased alveolar shadowing or hazziness\n3. respiratory symptoms like increase shortness of breath, cough with sputum Raised inflammatory markers suggesting of bacterial infection with either increased white cell count or C-reactive protein, or both\n\nExclusion Criteria:\n\n* Nosocomial pneumonia which is acquired \\>= 48 hours after hospital admission. Pneumonia which are already known to be caused by pathogens other than pneumococcus pneumoniae.'}, 'identificationModule': {'nctId': 'NCT05374018', 'briefTitle': 'Urinary Antigen Test for Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Prospective Study to Evaluate Stretococcus Pneumoniae Serotype Prevalence in Community Acquired Pneumonia in Hong Kong Using a Urinary Kit', 'orgStudyIdInfo': {'id': 'CREC 2020.34'}}, 'armsInterventionsModule': {'interventions': [{'name': 'urinary kit for pneumococcus antigen assay', 'type': 'DIAGNOSTIC_TEST', 'description': 'urine test for detection of pneumococcus antigen'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'KW To, MBChB', 'role': 'CONTACT', 'phone': '852 26322211'}, {'name': 'KW To, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'centralContacts': [{'name': 'KW To, MBChB', 'role': 'CONTACT', 'email': 'tokw617@yahoo.com.hk', 'phone': '35052211'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'To Kin Wang', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}