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

Clinical Study on Rapid Identification of Infectious Pathogens in Severe Pneumonia Patients Based on Bronchoscopic Imaging and Lung CT Guidance

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07308340
Acronym
IMG-GUIDE-IP
Enrollment
400
Registered
2025-12-29
Start date
2026-05-01
Completion date
2026-12-31
Last updated
2026-02-09

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

Conditions

Severe Pneumonia

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTStandalone 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.

DIAGNOSTIC_TESTBronchoscopic 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.

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy of Two Imaging Methods for Infectious Pathogens in Severe PneumoniaData collection will be completed retrospectively within 6 months after the last patient (admitted by 2025) is included; diagnostic accuracy analysis will be finished within 6 months after data collection.For each patient in the cohort, the diagnostic results of standalone lung CT and bronchoscopic imaging + lung CT will be compared with the "standard for pathogen diagnosis" (e.g., pathogen culture, nucleic acid detection, serological testing) to calculate two key indicators: 1. Sensitivity: The proportion of patients with positive gold standard results that are correctly identified as positive by the diagnostic method; \>2. Specificity: The proportion of patients with negative gold standard results that are correctly identified as negative by the diagnostic method. primary goal is to verify whether the combined imaging method (bronchoscopy + CT) has higher sensitivity and specificity than standalone CT for identifying infectious pathogens (including bacteria, fungi, and viruses).

Contacts

CONTACTHongxiang Li
li_hx@jlu.edu.cn86+15804301569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026