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

NCT07109310 | Not Yet Recruiting

• 1 other identifier: RTIModel-001
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  From 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

Study Arms (1)

Community-acquired pneumonia/sepsis group

Diagnostic Test: RTImodel001

Interventions

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

Community-acquired pneumonia/sepsis group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute respiratory tract infections

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Sepsis; Respiratory Distress Syndrome; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share