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O estudo clínico NCT07308340 (IMG-GUIDE-IP) para Pneumonia Grave está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Rapid Identification of Infectious Pathogens in Severe Pneumonia Guided by Bronchoscopic Imaging and Lung CT (IMG-GUIDE-IP) 400
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07308340 (IMG-GUIDE-IP) é um estudo observacional para Pneumonia Grave. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de maio de 2026, com o objetivo de incluir 400 participantes. Coordenado por The First Hospital of Jilin University e deve ser concluído em 31 de dezembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 9 de fevereiro de 2026.
Resumo
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...Mostrar mais
Título oficial
Clinical Study on Rapid Identification of Infectious Pathogens in Severe Pneumonia Patients Based on Bronchoscopic Imaging and Lung CT Guidance
Condições médicas
Pneumonia GraveOutros IDs do estudo
- IMG-GUIDE-IP
- IPID-2026
Número NCT
Data de início (real)
2026-05-01
Última atualização postada
2026-02-09
Data de conclusão (estimada)
2026-12-31
Inscrição (estimada)
400
Tipo de estudo
Observacional
Status
Ainda não recrutando
Palavras-chave
Severe Pneumonia
Infectious Pathogen Identification
Bronchoscopic Imaging
Lung CT
Retrospective Cohort Study
Infectious Pathogen Identification
Bronchoscopic Imaging
Lung CT
Retrospective Cohort Study
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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 ...Mostrar mais | 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. |
Desfecho primário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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. |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- 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 UniversityResponsável pelo estudo
Hongxiang Li, Investigador principal, Chief Physician, Associate Professor, PhD, The First Hospital of Jilin University
Contato central do estudo
Contato: Hongxiang Li, 86+15804301569, [email protected]
Sem dados de locais.