A Validation Study on a Prognostic Prediction Model for Respiratory Tract Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RTImodel001.
- Who it may be relevant to
- Registry conditions: Sepsis, Acute Respiratory Distress Syndrome, Community Acquired Pneumonia, Transcriptome. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Single-Center Clinical Validation Study of Transcri Ptomics-Based Biomarkers for Predicting Respiratory Infection Progression and Prognosis
Overview
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.
Interventions
- Diagnostic test 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
Primary outcome measures
- 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 outcome measures (2)
- 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]
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07109310 · RTIModel-001