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Набор скоро начнётся NCT06028178

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

— Наблюдательное Sepsis Emergent Infections, Treatment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Droplet digital PCR.
Кому может быть актуально
Состояния в реестре: Sepsis, Emergent Infections, Treatment. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест Droplet digital PCR
    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.

Первичные конечные точки

  • Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis [Срок оценки: 7days]
  • Prognostic value of ddPCR combined with transcriptomic analysis in suspected sepsis [Срок оценки: 28 days]
Вторичные конечные точки (4)
  • 7-day all-cause mortality rate [Срок оценки: 7 days]
  • 28-day all-cause mortality rate [Срок оценки: 28 days]
  • 90-day all-cause mortality rate [Срок оценки: 90 days]
  • Antimicrobial Resistance and antibiotic application [Срок оценки: 7 days]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06028178 · emergency medicine 20230824

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗