Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Molecular Diagnosis and Risk Stratification of Sepsis (MARS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01905033
Recruitment Status : Unknown
Verified April 2016 by T. van der Poll, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was:  Recruiting
First Posted : July 23, 2013
Last Update Posted : April 29, 2016
Sponsor:
Collaborators:
Center for Translational Molecular Medicine
UMC Utrecht
Radboud University
Philips Healthcare
Microbiome
Immunetrics
Check-Points
Biocartis
Immunexpress
Information provided by (Responsible Party):
T. van der Poll, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date July 11, 2013
First Posted Date July 23, 2013
Last Update Posted Date April 29, 2016
Study Start Date January 2011
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 18, 2013)
Molecular information about causative pathogens and the host response in patients with sepsis [ Time Frame: One year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01905033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 18, 2013)
Stratification of septic patients by severity and type of immune response to infection [ Time Frame: Five years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Diagnosis and Risk Stratification of Sepsis
Official Title Molecular Diagnosis and Risk Stratification of Sepsis
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, plasma, RNA, DNA.
Sampling Method Probability Sample
Study Population In 3-4 years all patients> 18 years in the Intensive Care Units of the AMC Amsterdam and UMC Utrecht will be included in the study with the exemption of elective cardiac surgery patients with an uncomplicated stay.
Condition Sepsis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 18, 2013)
7500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01905033
Other Study ID Numbers 10-056
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party T. van der Poll, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
  • Center for Translational Molecular Medicine
  • UMC Utrecht
  • Radboud University
  • Philips Healthcare
  • Microbiome
  • Immunetrics
  • Check-Points
  • Biocartis
  • Immunexpress
Investigators
Principal Investigator: Tom van der Poll, Prof. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date April 2016