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Enrolling by Invitation

NCT Number: NCT07113951

Diagnostic Application of AI-ROSE in Severe Pneumonia

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.

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Key information

Conditions

Severe Pneumonia Bacterial Infections Bacterial Infections and Mycoses Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fluorescence Biological Microscope

Nanjing, Jiangsu, 210036, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 2026-3-31

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Diagnostic Application of Microbiological Fluorescence Rapid On-site Evaluation Combined With Artificial Intelligence in Severe Pneumonia: a Multi-center Prospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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