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Clinical Trial NCT07308340 (IMG-GUIDE-IP) for Severe Pneumonia is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Rapid Identification of Infectious Pathogens in Severe Pneumonia Guided by Bronchoscopic Imaging and Lung CT (IMG-GUIDE-IP) 400

Not yet recruiting
Clinical Trial NCT07308340 (IMG-GUIDE-IP) is an observational study for Severe Pneumonia and is currently not yet recruiting. Enrollment is planned to begin on 1 May 2026 and continue until the study accrues 400 participants. Led by The First Hospital of Jilin University, this study is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 9 February 2026.
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), al...Show More
Official Title

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

Conditions
Severe Pneumonia
Other Study IDs
  • IMG-GUIDE-IP
  • IPID-2026
NCT ID Number
NCT07308340
Start Date (Actual)
2026-05-01
Last Update Posted
2026-02-09
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
400
Study Type
Observational
Status
Not yet recruiting
Keywords
Severe Pneumonia
Infectious Pathogen Identification
Bronchoscopic Imaging
Lung CT
Retrospective Cohort Study
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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 ...Show More
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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Diagnostic Accuracy of Two Imaging Methods for Infectious Pathogens in Severe Pneumonia
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).
Data 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.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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).

  • 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.
The First Hospital of Jilin University logoThe First Hospital of Jilin University
Study Responsible Party
Hongxiang Li, Principal Investigator, Chief Physician, Associate Professor, PhD, The First Hospital of Jilin University
Study Central Contact
Contact: Hongxiang Li, 86+15804301569, [email protected]
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