- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07574866
A Retrospective Study on Clinical Characteristics and Outcomes of Patients With Pneumonia
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Liang Peng, Doctor
- Phone Number: 86-020-85959142
- Email: pl_206@126.com
Study Locations
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-
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Guangzhou, China
- Fifth Affiliated Hospital of Guangzhou Medical University
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Contact:
- Liang Peng, Doctor
- Phone Number: 86-020-85959142
- Email: pl_206@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years old;
- Meet the diagnostic criteria for pneumonia (acute onset + new infiltrates on imaging);
- Have a positive result from pathogen testing;
- Time from onset to admission ≤ 72 hours (to ensure being in the acute phase of the disease);
Sign a written informed consent form.
Inclusion criteria for the severe group:
A diagnosis of "severe pneumonia" can be made if one of the main criteria or ≥ 3 of the secondary criteria are met.
Main criteria:
① Tracheal intubation requiring mechanical ventilation
② Need for vasoactive drugs after active fluid resuscitation for septic shock
Secondary criteria:
Respiratory rate ≥ 30 breaths/min
PaO₂/FiO₂ ≤ 250 mm Hg
Multiple lobe infiltrates
Confusion and/or disorientation ⑤ Blood urea nitrogen ≥ 20 mg/dL
⑥ Leukopenia (WBC < 4×10⁹/L)
Thrombocytopenia (PLT < 100×10⁹/L)
- Decreased body temperature (central body temperature < 36 ℃) ⑨ Hypotension requiring fluid resuscitation
Exclusion Criteria:
- 1) Patients with severely lacking medical records;
2) Those whose main manifestations are other non-infectious diseases (such as pulmonary edema, lung cancer, pulmonary embolism, etc.); 3) Those whose main diagnosis is active pulmonary tuberculosis, non-infectious interstitial lung disease, etc.; 4) Patients considered not applicable by the researchers.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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pneumonia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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28-day all-cause mortality rate
Time Frame: 28 days after admission
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28 days after admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic characteristics
Time Frame: 28 days after admission
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Demographic data (age, sex, etc.)
|
28 days after admission
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Comorbidities
Time Frame: 28 days after admission
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Comorbidities, such as chronic obstructive pulmonary disease (COPD), diabetes mellitus, and cardiovascular diseases.
|
28 days after admission
|
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Symptomatic manifestations
Time Frame: 28 days after admission
|
Symptomatic manifestations (e.g., fever, cough, dyspnea)
|
28 days after admission
|
|
Laboratory tests
Time Frame: 28 days after admission
|
Laboratory tests (including blood routine, liver and kidney function, etc.)
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28 days after admission
|
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Imaging Examination
Time Frame: 28 days after admission
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Imaging Examination: Radiological manifestations and image data from chest X-ray or CT scans
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28 days after admission
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ICU Length of Stay
Time Frame: 28 days after admission
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28 days after admission
|
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Duration of Mechanical Ventilation
Time Frame: 28 days after admission
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28 days after admission
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|
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Length of Hospital Stay
Time Frame: 28 days after admission
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28 days after admission
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Utilization of Antimicrobial Agents
Time Frame: 28 days after admission
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28 days after admission
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Clinical Outcomes (cured, improved, deceased)
Time Frame: 28 days after admission
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28 days after admission
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zifeng Yang, The First Affiliated Hospital of Guangzhou Medical University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-2026-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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