Rapid Identification of Infectious Pathogens in Severe Pneumonia Guided by Bronchoscopic Imaging and Lung CT

NCT ID: NCT07308340

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-31

Brief Summary

Severe pneumonia requires rapid and accurate diagnosis for targeted treatment, but single lung CT has limitations in identifying pathogens and distinguishing infectious/non-infectious etiologies. This is a retrospective self-controlled study enrolling patients diagnosed with severe pneumonia at the institution between 2024 and 2025 (recruitment will be extended 6-12 months if fewer than 400 patients are enrolled), all of whom underwent both single lung CT and bronchoscopy-combined CT examinations.

Clinical data will be collected retrospectively, including demographic information, bronchoscopic mucosal findings (e.g., congestion, exudation), lung CT lesion characteristics (e.g., consolidation, ground-glass opacity), and gold standard diagnostic results (pathogenic detection or clinical comprehensive diagnosis). The core objective is to compare the diagnostic precision between single lung CT and bronchoscopy-combined CT, focusing on accuracy, sensitivity, and specificity across three etiological subtypes (bacterial/fungal, viral, non-infectious).

Bronchoscopy complements CT by directly visualizing airway mucosal changes, while CT provides panoramic views of pulmonary lesions. Their combination is hypothesized to improve diagnostic accuracy. The findings aim to optimize diagnostic strategies for severe pneumonia, guiding clinicians to select more effective imaging approaches.

Conditions

Severe Pneumonia

Keywords

Severe Pneumonia; Infectious Pathogen Identification; Bronchoscopic Imaging; Lung CT; Retrospective Cohort Study

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Severe Pneumonia Patients with Dual Diagnostic Assessments

This retrospective cohort includes patients diagnosed with severe pneumonia who were admitted to the study institution between 2024 and 2025 (recruitment will be extended 6-12 months if fewer than 400 patients are enrolled). All patients in this cohort underwent two diagnostic procedures (standalone lung CT, and bronchoscopic imaging combined with lung CT) during their clinical management. The cohort is designed for self-controlled comparison: diagnostic accuracy of the two methods for infectious pathogen identification will be analyzed to verify the value of the combined imaging approach.

Standalone Lung CT for Severe Pneumonia Diagnosis

Intervention Type: DIAGNOSTIC_TEST

Standard chest CT scan (including plain scan and/or enhanced scan as clinically needed) performed to evaluate pulmonary lesion location, scope, and imaging features (e.g., consolidation, ground-glass opacity). The CT findings will be used to preliminarily infer the presence of infectious pathogens and guide initial clinical judgment.

Bronchoscopic Imaging + Lung CT for Severe Pneumonia diagnosis

Intervention Type: DIAGNOSTIC_TEST

Based on pre-existing lung CT images (to locate lesions), flexible bronchoscopy is performed to directly observe mucosal changes in the tracheobronchial tree (e.g., congestion, edema, exudation). Bronchoscopic imaging features are combined with CT findings to comprehensively judge the type of infectious pathogen (e.g., bacterial vs. viral) and improve diagnostic accuracy.

Interventions

Standalone Lung CT for Severe Pneumonia Diagnosis

Standard chest CT scan (including plain scan and/or enhanced scan as clinically needed) performed to evaluate pulmonary lesion location, scope, and imaging features (e.g., consolidation, ground-glass opacity). The CT findings will be used to preliminarily infer the presence of infectious pathogens and guide initial clinical judgment.

Intervention Type: DIAGNOSTIC_TEST

Bronchoscopic Imaging + Lung CT for Severe Pneumonia diagnosis

Based on pre-existing lung CT images (to locate lesions), flexible bronchoscopy is performed to directly observe mucosal changes in the tracheobronchial tree (e.g., congestion, edema, exudation). Bronchoscopic imaging features are combined with CT findings to comprehensively judge the type of infectious pathogen (e.g., bacterial vs. viral) and improve diagnostic accuracy.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients admitted to the study institution between January 2024 and December 2025, with a clinical diagnosis of severe pneumonia (consistent with the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia.
• Patients who underwent both standalone lung CT examination and bronchoscopic imaging examination during hospitalization; complete imaging reports and bronchoscopy operation records are available.
• Patients who completed at least one type of microbial standard test (as defined in Primary Outcome Measure: e.g., pathogen culture, nucleic acid detection, GM test); complete test reports are available.
• Medical Records: Complete electronic medical records are available, including demographic information (age, gender), clinical symptoms, treatment regimens, and prognosis data (length of hospital stay, in-hospital mortality).

Exclusion Criteria

• Imaging/Microbial Data Deficiency: Patients with incomplete imaging data (e.g., missing lung CT images, unrecorded bronchoscopic mucosal changes) or unavailable microbial gold standard test results.
• Bronchoscopy Contraindications: Patients who underwent bronchoscopic imaging for non-diagnostic purposes (e.g., foreign body removal, hemostasis) or had bronchoscopy-related complications (e.g., severe hemorrhage, pneumothorax) that affected examination completion.
• Duplicate Enrollment: Patients who were admitted multiple times for severe pneumonia during the study period; only the first admission is included to avoid duplicate data.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Hongxiang Li

Chief Physician, Associate Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hongxiang Li

Role: CONTACT

Phone: 86+15804301569

Email: li_hx@jlu.edu.cn

Other Identifiers

IPID-2026

Identifier Type: -

Identifier Source: org_study_id