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A Validation Study on a Prognostic Prediction Model for Respiratory Tract Infections | Clinical Trials | Clareo Health

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

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

NCT07109310•Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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

•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.

Key Dates

Start Date

August 15, 2025

Primary Completion Date

July 31, 2026

Completion Date

December 30, 2026

Last Updated

August 7, 2025

Enrollment

150

ESTIMATED participants

Conditions

SepsisAcute Respiratory Distress SyndromeCommunity Acquired PneumoniaTranscriptome

Interventions

RTImodel001

DIAGNOSTIC_TEST

Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm

NCT04850456

Critical IllnessSepsis, Severe

View study

RECRUITING

A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children

NCT04955210

Critical IllnessSevere Sepsis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm

A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children

Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit