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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06065618
Other study ID # YXLL-KY-2022(080)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 22, 2023
Est. completion date September 22, 2024

Study information

Verified date October 2023
Source Qianfoshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 22, 2024
Est. primary completion date September 22, 2024
Accepts healthy volunteers
Gender All
Age group 14 Years and older
Eligibility Inclusion Criteria: - Age > 14 years. - In the community. - Chest X-ray showed patchy, patchy infiltrative shadows or interstitial changes with or without pleural effusion (in or out of hospital) . - 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. Exclusion Criteria: - 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. - Human Immunodeficiency Virus. - The patient was readmitted within 72 hours of discharge and was classified as a single hospitalization.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Without intervention
Without intervention

Locations

Country Name City State
China Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The prevalence of CAP The prevalence of CAP Up to 12 months
Secondary Severity Assessment: Curb-65 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. Up to 12 months
Secondary Sputum culture According to the need for aerobic bacteria culture, anaerobic bacteria culture, Mycobacterium tuberculosis culture, or fungal culture, for the etiological diagnosis of respiratory infection. Up to 12 months
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