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Clinical Trials in China / NCT07567911
Starting soon Observational

A Prospective Observational Cohort Study Protocol for Disease Severity Stratification and Prognosis Assessment in Patients With Pneumonia

NCT07567911 · tracked via the Priya Life Science China tracker
Sponsor
Zhonghao Fang
Phase
Observational
Started
2026-05-01
Last updated
2026-05-05

Condition(s) studied

Severe PneumoniaPneumonia

Study summary

This is a prospective, multicenter observational cohort study involving approximately 2,700 patients, designed to delineate the natural history of pneumonia by tracking the complete clinical course and dynamic multi-omics evolution from the acute phase to recovery; the study aims to quantify severe conversion rates and mortality by comparing baseline characteristics, pathogen distribution, and immune response trajectories between severe and non-severe groups, ultimately revealing the underlying molecular mechanisms of disease progression and optimizing clinical risk stratification strategies.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
1. Inclusion and Exclusion Criteria for Pneumonia Patients 1.1 Inclusion Criteria 1) Age ≥ 18 years old; 2) Meeting the diagnostic criteria for pneumonia (acute onset + new infiltrates on imaging); 3) Time from onset to admission ≤ 72 hours; 4) Signed written informed consent. 1.1.1 Inclusion Criteria for Severe Pneumonia Patients 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 Requires mechanical ventilation with tracheal intubation ② Requires vasopressor drugs after aggressive 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) ⑦ Thrombocytopenia (PLT \< 100×10⁹/L) ⑧ Decreased body temperature (central body temperature \< 36 ℃) ⑨ Hypotension requiring fluid resuscitation 1.2 Exclusion Criteria 1. End-stage diseases (such as expected survival \< 48 hours); 2. Long-term immunosuppressive therapy (prednisone \> 20mg/d for more than 3 weeks, or neutropenia after chemotherapy); 3. Pregnant or lactating women. 2. Inclusion and Exclusion Criteria for Patients with Suspected Infection but Negative Pathogen Testing 2.1 Inclusion Criteria <!-- --> 1. Age ≥ 18 years old; 2. Having infection-related symptoms or signs (such as fever, cough, sputum production, elevated white blood cells, etc.), clinically suspected of pneumonia; 3. All pathogen tests are negative within 3 days after admission; 4. Time from onset to admission ≤ 72 hours; 5. Signed written informed consent. 2.2 Exclusion Criteria <!-- --> 1. End-stage diseases (such as expected survival \< 48 hours); 2. Long-term immunosuppressive therapy; 3. Pregnant or lactating women;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fifth Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

More Zhonghao Fang trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07567911 on ClinicalTrials.gov ↗ ← All trials in China