A Validation Study on a Prognostic Prediction Model for Respiratory Tract Infections
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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 population
Patients with acute respiratory tract infections
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
RTImodel001
Diagnostic testThis model was developed through transcriptome sequencing combined with machine learning to predict the risk of disease progression and clinical outcomes of respiratory tract infections
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Community-acquired pneumonia/sepsis group1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
The changes of the seven-scale compared to the time of enrollment
Time frame
From enrollment to the end of follow-up at 28 days2
The changes in SOFA score compared to the time of enrollment.
Time frame
From enrollment to the end of follow-up at 28 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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