Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06065618
Status:
UNKNOWN
Last Update Posted:
2023-10-10
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characteristics of Hospitalized Patients With Community-acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-09-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-29', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of CAP', 'timeFrame': 'Up to 12 months', 'description': 'The prevalence of CAP'}], 'secondaryOutcomes': [{'measure': 'Severity Assessment: Curb-65', 'timeFrame': 'Up to 12 months', 'description': 'Curb-65 is mainly used to evaluate the severity of pneumonia. The clinical indexes of curb-65 include: 1. Disturbance of consciousness, 2. Blood urea nitrogen \\> 7 mmol/L, 3. Respiratory frequency ≥30 times/min, 3. The severity of pneumonia 4. Systolic blood pressure \\< 90 mmhg or diastolic blood pressure ≤60 mmhg. 5. Age ≥65 years. If curb-65 score is 0-1, it is recommended that the patient be treated outside the hospital. Curb-65 has a score of 2 and is recommended for short-term hospitalization. If curb-65 score ≥3 indicates severe pneumonia, hospitalization or ICU treatment is recommended. With the increase of curb-65 score, the mortality of the patients will increase accordingly.'}, {'measure': 'Sputum culture', 'timeFrame': 'Up to 12 months', 'description': 'According to the need for aerobic bacteria culture, anaerobic bacteria culture, Mycobacterium tuberculosis culture, or fungal culture, for the etiological diagnosis of respiratory infection.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Community-acquired Pneumonia']}, 'descriptionModule': {'briefSummary': 'At present, the epidemiological characteristics and the distribution of pathogens of community-acquired pneumonia in Shandong Province are not clear. In order to understand the characteristics of community-acquired pneumonia, the distribution of pathogens and the risk factors of complications in Shandong Province, it is necessary to carry out investigation and study, which will provide the basis and support for the future prospective cohort study of pulmonary infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients aged over 14 years with community-acquired pneumonia were confirmed by imaging.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 14 years.\n* In the community.\n* Chest X-ray showed patchy, patchy infiltrative shadows or interstitial changes with or without pleural effusion (in or out of hospital) .\n* Pneumonia-related clinical manifestations: 1) recent cough, expectoration or respiratory disease symptoms aggravated, and the emergence of purulent sputum, with or without chest pain. 2) fever: armpit temperature ≥37.3℃ or hypothermia: armpit temperature \\<36℃. 3) signs of pulmonary consolidation and/or Wet Rales. 4) white blood cell \\> 10 × 10\\^9/L or \\< 4 × 10\\^9/L with or without left shift of nucleus. Comply with 1,2,3 above plus any one of 4 above.\n\nExclusion Criteria:\n\n* The patients were initially diagnosed with pulmonary neoplasms, tuberculosis, non-infectious interstitial disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophil granulocyte infiltration and pulmonary vasculitis.\n* Human Immunodeficiency Virus.\n* The patient was readmitted within 72 hours of discharge and was classified as a single hospitalization.'}, 'identificationModule': {'nctId': 'NCT06065618', 'briefTitle': 'Characteristics of Hospitalized Patients With Community-acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'A Retrospective Study on Disease Characteristics of Hospitalized Patients With Community-acquired Pneumonia', 'orgStudyIdInfo': {'id': 'YXLL-KY-2022(080)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Without intervention', 'type': 'OTHER', 'description': 'Without intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Qi, Dr.', 'role': 'CONTACT', 'email': 'qiqianqlh@163.com', 'phone': '+86 13706380314'}], 'facility': 'Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Qian Qi', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}