- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06065618
Characteristics of Hospitalized Patients With Community-acquired Pneumonia
October 6, 2023 updated by: Qian Qi, Qianfoshan Hospital
A Retrospective Study on Disease Characteristics of Hospitalized Patients With Community-acquired Pneumonia
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
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Jinan, Shandong, China, 250014
- Recruiting
- Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
-
Contact:
- Qian Qi, Dr.
- Phone Number: +86 13706380314
- Email: qiqianqlh@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
All patients aged over 14 years with community-acquired pneumonia were confirmed by imaging.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The prevalence of CAP
Time Frame: Up to 12 months
|
The prevalence of CAP
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity Assessment: Curb-65
Time Frame: Up to 12 months
|
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
|
|
Sputum culture
Time Frame: Up to 12 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2023
Primary Completion (Estimated)
September 22, 2024
Study Completion (Estimated)
September 22, 2024
Study Registration Dates
First Submitted
September 22, 2023
First Submitted That Met QC Criteria
September 29, 2023
First Posted (Actual)
October 4, 2023
Study Record Updates
Last Update Posted (Actual)
October 10, 2023
Last Update Submitted That Met QC Criteria
October 6, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YXLL-KY-2022(080)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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