Rapid Identification of Infectious Pathogens in Severe Pneumonia Guided by Bronchoscopic Imaging and Lung CT (IMG-GUIDE-IP)

Jilin University

Status: Not yet enrolling

Conditions: Severe Pneumonia

Treatments: Diagnostic Test: Bronchoscopic Imaging + Lung CT for Severe Pneumonia diagnosis; Diagnostic Test: Standalone Lung CT for Severe Pneumonia Diagnosis

Study type: Observational

Funder types: Other

Identifiers

NCT07308340

IPID-2026

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 1 patient group

Severe Pneumonia Patients with Dual Diagnostic Assessments

Description:

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.

Treatment:

Diagnostic Test: Standalone Lung CT for Severe Pneumonia Diagnosis

Diagnostic Test: Bronchoscopic Imaging + Lung CT for Severe Pneumonia diagnosis