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

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.

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Key information

Conditions

Sepsis Acute Respiratory Distress Syndrome Community Acquired Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Systemic Inflammatory Response Syndrome Transcriptome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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.

Exclusion criteria

Respiratory failure related to underlying heart and lung diseases;

Severe liver and kidney dysfunction, pregnancy or lactation period;

Meet the indications for organ transplantation or have undergone organ transplantation surgery in the past; ④ Known HIV infection; ⑤ Screening: Those who have experienced unstable angina pectoris or myocardial infarction within 30 days prior to the screening and have not received vascular recanalization treatment, as well as those with extensive cerebral hemorrhage; ⑥ Situations where researchers determine that enrollment is not appropriate.

Treatment and study plan

RTImodel001

Diagnostic Test

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

Primary outcomes

Any of the following occurs: 1) Death; 2) Progress to sepsis (SOFA≥2 points); 3) Follow up for 28 days.

Time frame: From enrollment to the end of follow-up at 28 days

Secondary outcomes

The changes of the seven-scale compared to the time of enrollment

Time frame: From enrollment to the end of follow-up at 28 days
The changes in SOFA score compared to the time of enrollment.

Time frame: From enrollment to the end of follow-up at 28 days

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 7, 2025
Registry last updated: Aug 7, 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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