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MARS: Molecular Diagnosis and Risk Stratification of Sepsis

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Unknown status
CT.gov ID
NCT01905033
Collaborator
Center for Translational Molecular Medicine (Other), UMC Utrecht (Other), Radboud University Medical Center (Other), Philips Healthcare (Industry), Microbiome (Other), Immunetrics (Other), Check-Points (Other), Biocartis (Industry), Immunexpress (Industry)
7,500
Enrollment
2
Locations
89
Duration (Months)
3750
Patients Per Site
42.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background: Sepsis is a major cause of in-hospital morbidity and mortality. Current tools available to the clinician to initiate therapy of patients with sepsis mainly comprise of symptom classification systems and culture techniques, which provide aspecific and slow information.

Objective: The ultimate goal of this program is to assist the physician at the bedside in tailoring the treatment of an individual patient suffering from sepsis by generating rapid molecular information about the causative pathogen and the host response.

Deliverables: Rapid tests ("sample-in-result-out") that can be used by health care personnel at or close to the bedside and that provide rapid information (within two hours) about the presence or absence of sepsis, the causative pathogen and the risk of the individual patient for sepsis complications and death.

Design: The program is organized into four Work Packages (WPs) along a clinical, discovery and technology platform. In WP1 two university hospitals will enroll 7500 patients admitted to the Intensive Care Unit during the first 3 years of the project; 25% - 40% of these patients will have or will develop sepsis. In WP2 (Pathogen Detection), blood obtained from these patients will be used to develop rapid, fully automated DNA-based bedside tests that identify microorganisms and also provide information about their resistance to antibiotics. In WP3 (Host Response), RNA from blood cells will be analyzed to find novel biomarkers and to develop rapid and easy to perform tests that provide information about the risk profile of the patient. In addition, plasma levels of selected protein biomarkers will be measured for comparison of their value with that of the identified leukocyte molecular signatures. WP4 is responsible for the ICT management of the project. The Clinical Platform (covered by WP1 and WP4) delivers patient data and biological samples to the discovery and technology platforms. The Discovery Platform (covered by WP2 and WP3) uses patient data and biological samples to develop tests for detection of the infectious agent causing sepsis and for stratification of patients according to their risk for sepsis complications, including death. The results generated within the discovery platform will be delivered to the technology platform. The Technology Platform (part of WP2 and WP3) has the specific aim to develop rapid assays that run on a fully automated (micro)fluidics platform that is so easy to operate that it can be used in decentralized settings such as (close to) the ICU. The developed assays will make use of the knowledge generated in the discovery platform.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    7500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Molecular Diagnosis and Risk Stratification of Sepsis
    Study Start Date :
    Jan 1, 2011
    Anticipated Primary Completion Date :
    Jun 1, 2018
    Anticipated Study Completion Date :
    Jun 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Molecular information about causative pathogens and the host response in patients with sepsis [One year]

    Secondary Outcome Measures

    1. Stratification of septic patients by severity and type of immune response to infection [Five years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients> 18 years in the Intensive Care Units of the AMC Amsterdam and UMC Utrecht.
    Exclusion Criteria:
    • Elective cardiac surgery patients with an uncomplicated stay.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Academic Medical Center Amsterdam Noord-Holland Netherlands 1105 AZ
    2 University Medical Center Utrecht Utrecht Netherlands 3584 CX

    Sponsors and Collaborators

    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    • Center for Translational Molecular Medicine
    • UMC Utrecht
    • Radboud University Medical Center
    • Philips Healthcare
    • Microbiome
    • Immunetrics
    • Check-Points
    • Biocartis
    • Immunexpress

    Investigators

    • Principal Investigator: Tom van der Poll, Prof., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    T. van der Poll, Prof. dr. T. van der Poll, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    ClinicalTrials.gov Identifier:
    NCT01905033
    Other Study ID Numbers:
    • 10-056
    First Posted:
    Jul 23, 2013
    Last Update Posted:
    Apr 29, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by T. van der Poll, Prof. dr. T. van der Poll, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
    Sepsis
    Pneumonia
    Peritonitis
    Biomarkers
    Transcriptomics
    Pathogen detection
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Apr 29, 2016