Severe PneumoniaIMG-GUIDE-IPNCT07308340
Rapid Identification of Infectious Pathogens in Severe Pneumonia Guided by Bronchoscopic Imaging and Lung CT
An observational study of Severe Pneumonia, run by The First Hospital of Jilin University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Pneumonia
- What is being tested?
- Standalone Lung CT for Severe Pneumonia Diagnosis and Bronchoscopic Imaging + Lung CT for Severe Pneumonia diagnosis
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients (≥18 years old) admitted to the study institution between January 2024 and December 2025, with a confirmed diagnosis of severe pneumonia (per Chinese clinical guidelines for community-acquired or hospital-acquired pneumonia). All included patients must have undergone both standalone lung CT and bronchoscopic imaging (CT-guided) during hospitalization, with complete imaging records. They also need to have completed at least one microbial gold standard test (e.g., pathogen culture, nucleic acid detection) with available reports, and intact electronic medical records (demographics, treatment, prognosis). Patients are excluded if they have incomplete imaging/microbial data, bronchoscopy for non-diagnostic purposes, duplicate admissions, or are under 18 years old.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on Rapid Identification of Infectious Pathogens in Severe Pneumonia Patients Based on Bronchoscopic Imaging and Lung CT Guidance
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
- Being tested
- Standalone Lung CT for Severe Pneumonia Diagnosis, Bronchoscopic Imaging + Lung CT for Severe Pneumonia diagnosis
- Keywords
- Severe Pneumonia, Infectious Pathogen Identification, Bronchoscopic Imaging, Lung CT, Retrospective Cohort Study
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standalone Lung CT for Severe Pneumonia DiagnosisDiagnostic 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 diagnosisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Standalone Lung CT for Severe Pneumonia Diagnosis; Diagnostic Test: Bronchoscopic Imaging + Lung CT for Severe Pneumonia diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe PneumoniaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxiang Li, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308340
- Sponsor's protocol ID
- IPID-2026
- Acronym
- IMG-GUIDE-IP
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified individual participant data (IPD) that includes: Demographic information (e.g., age, gender); Baseline clinical characteristics (e.g., disease stage, results of relevant laboratory tests); Intervention-associated data (e.g., diagnostic findings from computed tomography (CT) alone and combined with bronchoscopy); Outcome measures (the accuracy of diagnosis for severe pneumonia); Safety data (e.g., documentation of adverse events). To safeguard participant privacy, all shared data will be fully de-identified by removing direct identifiers (e.g., full name, contact details, medical record number).
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Rapid Identification of Infectious Pathogens in Severe Pneumonia Patients Based on Bronchoscopic Imaging and Lung CT Guidance
- ClinicalTrials.gov ID
- NCT07308340
- Acronym / sponsor ID
- IMG-GUIDE-IP / IPID-2026
- Conditions
- Severe Pneumonia
- Keywords
- Severe Pneumonia, Infectious Pathogen Identification, Bronchoscopic Imaging, Lung CT, Retrospective Cohort Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Pneumonia Patients with Dual Diagnostic Assessments | – | Diagnostic Test: Standalone Lung CT for Severe Pneumonia Diagnosis, Diagnostic Test: Bronchoscopic Imaging + Lung CT for Severe Pneumonia diagnosisThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients (≥18 years old) admitted to the study institution between January 2024 and December 2025, with a confirmed diagnosis of severe pneumonia (per Chinese clinical guidelines for community-acquired or hospital-acquired pneumonia). All included patients must have undergone both standalone lung CT and bronchoscopic imaging (CT-guided) during hospitalization, with complete imaging records. They also need to have completed at least one microbial gold standard test (e.g., pathogen culture, nucleic acid detection) with available reports, and intact electronic medical records (demographics, treatment, prognosis). Patients are excluded if they have incomplete imaging/microbial data, bronchoscopy for non-diagnostic purposes, duplicate admissions, or are under 18 years old.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standalone Lung CT for Severe Pneumonia DiagnosisStandard 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 test | Severe Pneumonia Patients with Dual Diagnostic Assessments |
| Bronchoscopic Imaging + Lung CT for Severe Pneumonia diagnosisBased 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. | Diagnostic test | Severe Pneumonia Patients with Dual Diagnostic Assessments |
Primary outcome
Diagnostic Accuracy of Two Imaging Methods for Infectious Pathogens in Severe Pneumonia
Time frame: 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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. We plan to share de-identified individual participant data (IPD) that includes: Demographic information (e.g., age, gender); Baseline clinical characteristics (e.g., disease stage, results of relevant laboratory tests); Intervention-associated data (e.g., diagnostic findings from computed tomography (CT) alone and combined with bronchoscopy); Outcome measures (the accuracy of diagnosis for severe pneumonia); Safety data (e.g., documentation of adverse events). To safeguard participant privacy, all shared data will be fully de-identified by removing direct identifiers (e.g., full name, contact details, medical record number).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Pneumonia, run by The First Hospital of Jilin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongxiang Li (86+15804301569, li_hx@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Two Imaging Methods for Infectious Pathogens in Severe Pneumonia (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.