Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01905033
Status:
UNKNOWN
Last Update Posted:
2016-04-29
First Post:
2013-07-11
Brief Title:
Molecular Diagnosis and Risk Stratification of Sepsis
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Molecular Diagnosis and Risk Stratification of Sepsis
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MARS
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 microfluidics 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
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 microfluidics 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None