Community-acquired PneumoniaNCT06065618
Characteristics of Hospitalized Patients With Community-acquired Pneumonia
An observational study of Community-acquired Pneumonia, run by Qianfoshan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Without intervention
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2023to 22 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Child, Adult, Older adult
Study population: All patients aged over 14 years with community-acquired pneumonia were confirmed by imaging.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- 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
Jinan, Shandong, 250014
Qian Qi, Dr., +86 13706380314, qiqianqlh@163.com
About this study
Official title: 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.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Without intervention
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without interventionOther
Without intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of CAP
The prevalence of CAP
Measured: Up to 12 months
Secondary outcomes (2)
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start22 Sep 2023
- Primary completion22 Sep 2024 (estimated)
- Study completion22 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065618
- Sponsor's protocol ID
- YXLL-KY-2022(080)
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on Disease Characteristics of Hospitalized Patients With Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT06065618
- Acronym / sponsor ID
- YXLL-KY-2022(080)
- Conditions
- Community-acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 22 Sep 2024 (estimated)
- Study completion
- 22 Sep 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients aged over 14 years with community-acquired pneumonia were confirmed by imaging.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Without interventionWithout intervention | Other | – |
Primary outcome
The prevalence of CAP
Time frame: Up to 12 months
The prevalence of CAP
2 secondary outcomes
Severity Assessment: Curb-65
Time frame: Up to 12 months
Sputum culture
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of CAP (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.