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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07109310
Enrollment
150
Registered
2025-08-07
Start date
2025-08-15
Completion date
2026-12-30
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DIAGNOSTIC_TESTRTImodel001

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

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Community-acquired pneumonia group * Age ≥18 years old; * Sign the informed consent form; ③ According to the researcher's judgment, be able to comply with the research visit; ④ Comply with the diagnostic criteria for community-acquired pneumonia in the Chinese Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults (2016 Edition); ⑤ The time from onset to enrollment was ≤8 days. Sepsis Group * Age ≥18 years old; * Sign the informed consent form; ③ According to the researcher's judgment, be able to comply with the research visit; * Patients who meets the sepsis 3.0 diagnostic criteria.

Design outcomes

Primary

MeasureTime frame
Any of the following occurs: 1) Death; 2) Progress to sepsis (SOFA≥2 points); 3) Follow up for 28 days.From enrollment to the end of follow-up at 28 days

Secondary

MeasureTime frame
The changes of the seven-scale compared to the time of enrollmentFrom enrollment to the end of follow-up at 28 days
The changes in SOFA score compared to the time of enrollment.From enrollment to the end of follow-up at 28 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026