NCT07109310

A Validation Study on a Prognostic Prediction Model for Respiratory Tract Infections

A Prospective, Single-Center Clinical Validation Study of Transcri Ptomics-Based Biomarkers for Predicting Respiratory Infection Progression and Prognosis

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study adopted a prospective, single-center, open-label design, aiming to evaluate the efficacy of the RTI clinical outcome prediction model in predicting clinical outcomes in subjects with acute respiratory tract infections. In this study, the subjects were divided into the community-acquired pneumonia group and the sepsis group, including one baseline visit, one visit on the 7th day, and one visit on the 28th day. During the research process, blood samples will be collected at the corresponding visiting points for the validation of the predictive model.

Conditions

• Sepsis
• Acute Respiratory Distress Syndrome
• Community Acquired Pneumonia
• Transcriptome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	RTImodel001	This model was developed through transcriptome sequencing combined with machine learning to predict the risk of disease progression and clinical outcomes of respiratory tract infections

Timeline

• Start date: 2025-08-15
• Primary completion: 2026-07-31
• Completion: 2026-12-30
• First posted: 2025-08-07
• Last updated: 2025-08-07