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

NCT06028178 | Not Yet Recruiting DMC

• 1 other identifier: emergency medicine 20230824
• Study Type: observational
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sepsis; Emergent Infections, Treatment

Keywords

Droplet digital PCR; Transcriptomic molecular target assay

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 7-day all-cause mortality rate

  7 days

• 28-day all-cause mortality rate

  28 days

• 90-day all-cause mortality rate

  90 days

• Antimicrobial Resistance and antibiotic application

  7 days

Study Arms (2)

Experimental group

The experimental group will recruit 300 participants undergoing blood culture, droplet digital PCR and transcriptome analysis.

Diagnostic Test: Droplet digital PCR

Control group

The control group will recruit 60 participants undergoing blood culture only.

Interventions

Droplet digital PCR DIAGNOSTIC_TEST

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.

Also known as: Transcriptomic analysis

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective inclusion of patients with suspected sepsis with MSS ≥ 2 in the emergency department of Shanghai East Hospital, Shanghai Pudong New District Zhoupu Hospital, Shanghai Pudong New District Gongli Hospital, Shanghai Pudong Hospital and Shanghai Punan Hospital Hospital, Shanghai Pudong Hospital, Shanghai Pudong New Area Hospital and Shanghai Pudong New Area Punan Hospital. The patients will be randomized by stratified grouping and assigned to two parallel groups in the ratio of 5:1.

You may qualify if:

• age ≥ 18 years, regardless of sex
• MSS≥2 score
• written informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai East Hospital: lead

MeSH Terms

Conditions

Sepsis; Breakthrough Infections

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 8, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 years