xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06028178</url>
    </required_header>
    <id_info>
      <org_study_id>emergency medicine 20230824</org_study_id>
      <nct_id>NCT06028178</nct_id>
    </id_info>
    <brief_title>Droplet Digital PCR Combines With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department</brief_title>
    <official_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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai East Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai East Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Rapid identification of pathogens and early warning of host response are key to improve the&#xD;
        prognosis of sepsis. Establishing a comprehensive identification system based on pathogen&#xD;
        identification and host immune status is an effective way to achieve early warning&#xD;
        stratification of patients with infections in the emergency department. This prospective&#xD;
        multicenter clinical study will combine droplet digital PCR (ddPCR) and transcriptomic&#xD;
        molecular target assay for validation in patients with suspected sepsis in the emergency&#xD;
        department. The purpose is to (1) compare the efficacy of ddPCR with blood culture for early&#xD;
        diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets&#xD;
        based on 29 messenger RNA for the presence or absence of infection as well as infectious&#xD;
        agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and&#xD;
        therapeutic monitoring value of ddPCR combined with transcriptome analysis methods.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rapid identification of pathogens and early warning of host response are key to improve the&#xD;
        prognosis of sepsis. Establishing a comprehensive identification system based on pathogen&#xD;
        identification and host immune status is an effective way to achieve early warning&#xD;
        stratification of patients with infections in the emergency department. Therefore, based on&#xD;
        our preliminary single-center study, this prospective multicenter clinical study will combine&#xD;
        droplet digital PCR (ddPCR) and transcriptomic molecular target assay for validation in&#xD;
        patients with suspected sepsis in the emergency department. The purpose is to (1) compare the&#xD;
        efficacy of ddPCR with blood culture for early diagnosis and prognosis; (2) assess the&#xD;
        diagnostic value of transcriptomic molecular targets based on 29 messenger RNA for the&#xD;
        presence or absence of infection as well as infectious agents, and to evaluate their efficacy&#xD;
        for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddPCR&#xD;
        combined with transcriptome analysis methods. In a word, this study will be undertaken to&#xD;
        assess the diagnostic and therapeutic monitoring value of early warning models for sepsis in&#xD;
        emergency department and to promote them to improve the identification ability of emergency&#xD;
        infections.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>90 Days</target_duration>
    <primary_outcome>
      <measure>Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis</measure>
      <time_frame>7days</time_frame>
      <description>Diagnostic efficiency of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prognostic value of ddPCR combined with transcriptomic analysis in suspected sepsis</measure>
      <time_frame>28 days</time_frame>
      <description>Prognostic value of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>7-day all-cause mortality rate</measure>
      <time_frame>7 days</time_frame>
      <description>Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>28-day all-cause mortality rate</measure>
      <time_frame>28 days</time_frame>
      <description>Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>90-day all-cause mortality rate</measure>
      <time_frame>90 days</time_frame>
      <description>Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antimicrobial Resistance and antibiotic application</measure>
      <time_frame>7 days</time_frame>
      <description>Evaluation of combined examination by ddPCR and transcriptomic analysis for the the value of guiding clinical drug therapy.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">360</enrollment>
    <condition>Sepsis</condition>
    <condition>Emergent Infections, Treatment</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <description>The experimental group will recruit 300 participants undergoing blood culture, droplet digital PCR and transcriptome analysis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>The control group will recruit 60 participants undergoing blood culture only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Droplet digital PCR</intervention_name>
      <description>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.</description>
      <arm_group_label>Experimental group</arm_group_label>
      <other_name>Transcriptomic analysis</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Prospective inclusion of patients with suspected sepsis with MSS ≥ 2 in the emergency&#xD;
          department of Shanghai East Hospital, Shanghai Pudong New District Zhoupu Hospital,&#xD;
          Shanghai Pudong New District Gongli Hospital, Shanghai Pudong Hospital and Shanghai Punan&#xD;
          Hospital Hospital, Shanghai Pudong Hospital, Shanghai Pudong New Area Hospital and Shanghai&#xD;
          Pudong New Area Punan Hospital. The patients will be randomized by stratified grouping and&#xD;
          assigned to two parallel groups in the ratio of 5:1.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age ≥ 18 years, regardless of sex&#xD;
  &#xD;
            -  MSS≥2 score&#xD;
  &#xD;
            -  written informed consent obtained&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt; 18 years, regardless of sex&#xD;
  &#xD;
            -  Patient's ICU length of stay &lt;24 hours&#xD;
  &#xD;
            -  Malignant tumor, HIV patients or any terminal-stage disease&#xD;
  &#xD;
            -  Known pregnancy or lactation&#xD;
  &#xD;
            -  Participation in other clinical trials&#xD;
  &#xD;
            -  Inadequate clinical information or missing experimental data&#xD;
  &#xD;
            -  No signed informed consent obtained&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Droplet digital PCR</keyword>
    <keyword>Transcriptomic molecular target assay</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Toxemia</mesh_term>
      <mesh_term>Emergencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All individual participant data that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>3 years</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06028178
  org study id: emergency medicine 20230824
  nct id: NCT06028178
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Case-Control
  time perspective: Prospective
  measure: Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis
  time frame: 7days
  description: Diagnostic efficiency of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine
  measure: Prognostic value of ddPCR combined with transcriptomic analysis in suspected sepsis
  time frame: 28 days
  description: Prognostic value of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine
  measure: 7-day all-cause mortality rate
  time frame: 7 days
  description: Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.
  measure: 28-day all-cause mortality rate
  time frame: 28 days
  description: Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.
  measure: 90-day all-cause mortality rate
  time frame: 90 days
  description: Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.
  measure: Antimicrobial Resistance and antibiotic application
  time frame: 7 days
  description: Evaluation of combined examination by ddPCR and transcriptomic analysis for the the value of guiding clinical drug therapy.
  arm group label: Experimental group
  description: The experimental group will recruit 300 participants undergoing blood culture, droplet digital PCR and transcriptome analysis.
  arm group label: Control group
  description: The control group will recruit 60 participants undergoing blood culture only.
  intervention type: Diagnostic Test
  intervention name: Droplet digital PCR
  description: 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.
  arm group label: Experimental group
  other name: Transcriptomic analysis
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Emergencies
  sharing ipd: Yes
  ipd description: All individual participant data that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: 3 years