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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

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

Вторичные конечные точки (2)

• The changes of the seven-scale compared to the time of enrollment [Срок оценки: From enrollment to the end of follow-up at 28 days]
• The changes in SOFA score compared to the time of enrollment. [Срок оценки: From enrollment to the end of follow-up at 28 days]

Критерии участия

Критерии включения

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.

Критерии исключения

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07109310 · RTIModel-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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