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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

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

Treatments: Diagnostic Test: RTImodel001

Study type: Observational

Funder types: Other

Identifiers

NCT07109310

RTIModel-001

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

150 participants in 1 patient group

Community-acquired pneumonia/sepsis group

Treatment:

Diagnostic Test: RTImodel001