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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07567911

Enrollment

2700

Registered

2026-05-05

Start date

2026-05-01

Completion date

2028-05-28

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Severe Pneumonia

Keywords

pneumonia, severe pneumonia

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
28-day all-cause mortality	28-day period following enrollment

Secondary

Measure	Time frame
The incidence rate of patients in the non-severe group progressing to severe condition	28-day period following enrollment
Time taken for the non-severe group to progress to the severe stage	28-day period following enrollment
Duration of ICU stay	28-day period following enrollment
Duration of mechanical ventilation	28-day period following enrollment
Total hospitalization days	28-day period following enrollment
28-day readmission rate	28-day period following enrollment

Countries

China

Contacts

CONTACTLiang Peng, Doctor

pl_206@126.com86-020-85959142

STUDY_CHAIRZifeng Yang, Doctor

The First Affiliated Hospital of Guangzhou Medical University

Outcome results