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

NCT ID: NCT07109310

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-12-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Community-acquired pneumonia/sepsis group

RTImodel001

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xinlun Tian

Chief physician, professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

RTIModel-001

Identifier Type: -

Identifier Source: org_study_id