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NCT Number: NCT06028178

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Transcriptomic analysis

Primary outcomes

  1. Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis

    Time frame: 7days

    Diagnostic efficiency of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine

  2. Prognostic value of ddPCR combined with transcriptomic analysis in suspected sepsis

    Time frame: 28 days

    Prognostic value of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine

Secondary outcomes

  1. 7-day all-cause mortality rate

    Time frame: 7 days

    Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.

  2. 28-day all-cause mortality rate

    Time frame: 28 days

    Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.

  3. 90-day all-cause mortality rate

    Time frame: 90 days

    Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.

  4. Antimicrobial Resistance and antibiotic application

    Time frame: 7 days

    Evaluation of combined examination by ddPCR and transcriptomic analysis for the the value of guiding clinical drug therapy.

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2023
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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