A Validation Study on a Prognostic Prediction Model for Respiratory Tract Infections (NCT07109310) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Validation Study on a Prognostic Prediction Model for Respiratory Tract Infections
150 participantsStarted 2025-08-15
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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; â‘¢ 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.
What they're measuring
1
Any of the following occurs: 1) Death; 2) Progress to sepsis (SOFA≥2 points); 3) Follow up for 28 days.
Timeframe: From enrollment to the end of follow-up at 28 days