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

NCT07567911 | Not Yet Recruiting

• 1 other identifier: P-2026-001
• Study Type: observational
• Target: 2,700
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Pneumonia; Pneumonia

Keywords

pneumonia; severe pneumonia

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

  28-day period following enrollment

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Multimodal omics analysis

  Day 0

Study Arms (3)

pneumonia

Severe pneumonia

Non-infection control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may not qualify if:

• 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 ℃)
• End-stage diseases (such as expected survival \< 48 hours);
• Long-term immunosuppressive therapy (prednisone \> 20mg/d for more than 3 weeks, or neutropenia after chemotherapy);
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Sponsors & Collaborators

• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator
• Zhonghao Fang: lead

Study Sites (1)

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and deep sputum

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zifeng Yang, Doctor

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Liang Peng, Doctor

CONTACT

86-020-85959142; pl_206@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 28, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)