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

ConditionsSevere Pneumonia Pneumonia

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorZhonghao Fang

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion and

Disqualifiers

Respiratory rate ≥ 30 breaths/min

PaO₂/FiO₂ ≤ 250 mm Hg

Multiple lobe infiltrates

Confusion and/or disorientation

Trial population

Based on the reported overall hospital mortality rate of pneumonia of 0.80%1, to ensure the accuracy of the estimation of the primary outcome (overall hospital mortality rate), a two-sided significance level of α = 0.05 was set, with an allowable absolute error of δ = 0.6%. Using the single sample rate formula, the minimum sample size N ≈ 2010 cases was calculated. Considering that this study is a real-world observational cohort design and needs to meet requirements such as multi-subgroup analysis, sensitivity testing, and machine learning modeling, the final plan is to include at least 2400 patients with pneumonia. Given that severe pneumonia accounts for approximately 13.58% to 20.05% of pneumonia patients1,2, an epidemiological proportion of 15% (i.e., 1.5:8.5) was taken. It is estimated that there will be approximately 360 patients with severe pneumonia and about 2040 patients with non-severe pneumonia. Additionally, this study also included 300 hospitalized patients with suspected

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,700 Participants

are grouped into 3 trial groups

Group A: pneumonia

Group B: Severe pneumonia

Group C: Non-infection control group