Diagnostic Application of AI-ROSE in Severe Pneumonia

NCT07113951 | Enrolling By Invitation DMC

• 1 other identifier: 2025-SR-567
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

AI-ROSE is an innovative immunofluorescence staining combined with artificial intelligence image analysis technology that uses a fully automated fluorescence microscope to image pathogens in real time. AI algorithms automatically identify pathogen types (such as bacteria, fungi, etc.) and cellular backgrounds, quickly interpret results, and automatically issue color graphic reports for clinical doctors to take earlier and more accurate targeted treatment for critically ill patients. This study used bronchoalveolar lavage fluid as a biological sample and compared it with traditional examination methods to analyze the diagnostic accuracy and clinical practicality of AI-ROSE in patients with severe pneumonia.

Conditions

Severe Pneumonia; Bacterial Infections

Keywords

Severe Pneumonia; artificial intelligence; Rapid on-site evaluation; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Comparing the diagnostic accuracy of AI-ROSE with traditional bronchoalveolar lavage fluid examination methods.

  2026-3-31

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Infected severe pneumonia patients

You may qualify if:

• Age 18 years and above
• The preliminary clinical diagnosis is a patient with lower respiratory tract infection
• Meets the criteria for severe pneumonia, which means one of the following conditions exists: ① Main criteria: septic shock requiring vasoactive drug support; Respiratory failure requiring mechanical ventilation; ② Secondary criteria: Meet at least 3 or more criteria, including respiratory rate\>30 times/minute; Oxygenation index (PaO ₂/FiO ₂)\<250; Multiple leaf segment infiltration; Consciousness disorders/orientation disorders; Urea nitrogen level\>20mg/dL; White blood cell count\<4 \* 10 \^ 9/L; platelet count\<100 \* 10 \^ 9/L; core body temperature\<36.8 ° C; hypotension requiring active fluid resuscitation
• The patient agrees to undergo bronchoscopy and bronchoalveolar lavage, and agrees to perform AI-ROSE testing on the bronchoalveolar lavage fluid

You may not qualify if:

• Patients with poor basic condition, severe illness, and inability to tolerate bronchoscopy examination
• The bronchoalveolar lavage fluid sample is not qualified

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Fluorescence Biological Microscope

Nanjing, Jiangsu, 210036, China

Location

MeSH Terms

Conditions

Pneumonia; Bacterial Infections; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections and Mycoses; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenkui Sun

  First Affiliated Hospital of Nanjing Medical University Nanjing

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)