Droplet Digital PCR Combines With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department

Study Overview
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Brief Summary
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Rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. Establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the emergency department. This prospective multicenter clinical study will combine droplet digital PCR (ddPCR) and transcriptomic molecular target assay for validation in patients with suspected sepsis in the emergency department. The purpose is to (1) compare the efficacy of ddPCR with blood culture for early diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets based on 29 messenger RNA for the presence or absence of infection as well as infectious agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddPCR combined with transcriptome analysis methods.

Detailed Description
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Rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. Establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the emergency department. Therefore, based on our preliminary single-center study, this prospective multicenter clinical study will combine droplet digital PCR (ddPCR) and transcriptomic molecular target assay for validation in patients with suspected sepsis in the emergency department. The purpose is to (1) compare the efficacy of ddPCR with blood culture for early diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets based on 29 messenger RNA for the presence or absence of infection as well as infectious agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddPCR combined with transcriptome analysis methods. In a word, this study will be undertaken to assess the diagnostic and therapeutic monitoring value of early warning models for sepsis in emergency department and to promote them to improve the identification ability of emergency infections.

Official Title
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Clinical Evaluation of Droplet Digital Polymerase Chain Reaction in Combination With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department: A Multicenter Prospective Observational Study

Conditions
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Sepsis, Emergent Infections, Treatment

Intervention / Treatment
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* Diagnostic Test: Droplet digital PCR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years, regardless of sex MSS≥2 score written informed consent obtained Exclusion Criteria: Age < 18 years, regardless of sex Patient's ICU length of stay <24 hours Malignant tumor, HIV patients or any terminal-stage disease Known pregnancy or lactation Participation in other clinical trials Inadequate clinical information or missing experimental data No signed informed consent obtained

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group<br>The experimental group will recruit 300 participants undergoing blood culture, droplet digital PCR and transcriptome analysis. | Diagnostic Test: Droplet digital PCR<br>* Droplet digital PCR has potential in resolving polymicrobial infection because it simultaneously achieves unprecedented high sensitivity , high specificity, and absolute quantification without the need for a standard curve.<br>* Other names: Transcriptomic analysis;|
| Control group<br>The control group will recruit 60 participants undergoing blood culture only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis | Diagnostic efficiency of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine | 7days | 
| Prognostic value of ddPCR combined with transcriptomic analysis in suspected sepsis | Prognostic value of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day all-cause mortality rate | Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis. | 7 days | 
| 28-day all-cause mortality rate | Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis. | 28 days | 
| 90-day all-cause mortality rate | Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis. | 90 days | 
| Antimicrobial Resistance and antibiotic application | Evaluation of combined examination by ddPCR and transcriptomic analysis for the the value of guiding clinical drug therapy. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Droplet digital PCR, Transcriptomic molecular target assay