SepsisMARSNCT01905033
Molecular Diagnosis and Risk Stratification of Sepsis
An observational study of Sepsis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 7,500 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2011to Jun 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients> 18 years in the Intensive Care Units of the AMC Amsterdam and UMC Utrecht.
Who cannot join
- Elective cardiac surgery patients with an uncomplicated stay.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 1 recruiting
- Completed
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
- Recruiting
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
Marc J Bonten, Prof., mbonten@umcutrecht.nl
Marc J. Bonten, Prof.
About this study
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.
Read more
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.
- Conditions
- Sepsis
- Keywords
- Sepsis, Pneumonia, Peritonitis, Biomarkers, Transcriptomics, Pathogen detection
- Medical subject headings
- Sepsis, Pneumonia, Peritonitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular information about causative pathogens and the host response in patients with sepsis
Measured: One year
Secondary outcomes (1)
Stratification of septic patients by severity and type of immune response to infection
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Translational Molecular Medicine, UMC Utrecht, Radboud University Medical Center, Philips Healthcare, Microbiome, Immunetrics, Check-Points, Biocartis NV, Immunexpress
- Responsible party
- Principal investigator, T. van der Poll, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Tom van der Poll, Prof., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905033
- Sponsor's protocol ID
- 10-056
- Acronym
- MARS
- Status last verified
- Apr 2016
- First submitted
- 11 Jul 2013
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Scicluna BP, Cano-Gamez K, Burnham KL, Davenport EE, Moore AR, Khan S, Hinds CJ, Cremer OL, Khatri P, Sweeney TE, Knight JC, van der Poll T. A consensus blood transcriptomic framework for sepsis. Nat Med. 2025 Dec;31(12):4119-4130. doi: 10.1038/s41591-025-03964-5. Epub 2025 Sep 30.
PubMed 41028542Filippini DFL, Jiang M, Kramer L, van der Poll T, Cremer O, Hla TTW, Retter A, Bos LDJ; MARS consortium. Plasma H3.1 nucleosomes as biomarkers of infection, inflammation and organ failure. Crit Care. 2025 May 19;29(1):198. doi: 10.1186/s13054-025-05415-6.
PubMed 40390092Brands X, Uhel F, van Vught LA, Wiewel MA, Hoogendijk AJ, Lutter R, Schultz MJ, Scicluna BP, van der Poll T. Immune suppression is associated with enhanced systemic inflammatory, endothelial and procoagulant responses in critically ill patients. PLoS One. 2022 Jul 25;17(7):e0271637. doi: 10.1371/journal.pone.0271637. eCollection 2022.
PubMed 35877767Peters-Sengers H, Butler JM, Uhel F, Schultz MJ, Bonten MJ, Cremer OL, Scicluna BP, van Vught LA, van der Poll T; MARS consortium. Source-specific host response and outcomes in critically ill patients with sepsis: a prospective cohort study. Intensive Care Med. 2022 Jan;48(1):92-102. doi: 10.1007/s00134-021-06574-0. Epub 2021 Dec 13.
PubMed 34902047Frencken JF, van Smeden M, van de Groep K, Ong DSY, Klein Klouwenberg PMC, Juffermans N, Bonten MJM, van der Poll T, Cremer OL; MARS Consortium. Etiology of Myocardial Injury in Critically Ill Patients with Sepsis: A Cohort Study. Ann Am Thorac Soc. 2022 May;19(5):773-780. doi: 10.1513/AnnalsATS.202106-689OC.
PubMed 34784496Pereverzeva L, Uhel F, Peters Sengers H, Cremer OL, Schultz MJ, Bonten MMJ, Scicluna BP, van der Poll T; MARS consortium. Association between delay in intensive care unit admission and the host response in patients with community-acquired pneumonia. Ann Intensive Care. 2021 Sep 28;11(1):142. doi: 10.1186/s13613-021-00930-5.
PubMed 34585271Brands X, de Vries FMC, Uhel F, Haak BW, Peters-Sengers H, Schuurman AR, van Engelen TSR, Lutter R, Cremer OL, Bonten MJ, Schultz MJ, Scicluna BP, van der Poll T; MARS Consortium. Plasma Ferritin as Marker of Macrophage Activation-Like Syndrome in Critically Ill Patients With Community-Acquired Pneumonia. Crit Care Med. 2021 Nov 1;49(11):1901-1911. doi: 10.1097/CCM.0000000000005072.
PubMed 33935163Simonis FD, Schouten LRA, Cremer OL, Ong DSY, Amoruso G, Cinella G, Schultz MJ, Bos LD; MARS consortium. Prognostic classification based on P/F and PEEP in invasively ventilated ICU patients with hypoxemia-insights from the MARS study. Intensive Care Med Exp. 2020 Dec 18;8(Suppl 1):43. doi: 10.1186/s40635-020-00334-y.
PubMed 33336322Uhel F, Peters-Sengers H, Falahi F, Scicluna BP, van Vught LA, Bonten MJ, Cremer OL, Schultz MJ, van der Poll T; MARS consortium. Mortality and host response aberrations associated with transient and persistent acute kidney injury in critically ill patients with sepsis: a prospective cohort study. Intensive Care Med. 2020 Aug;46(8):1576-1589. doi: 10.1007/s00134-020-06119-x. Epub 2020 Jun 8.
PubMed 32514599Klein Klouwenberg PMC, Spitoni C, van der Poll T, Bonten MJ, Cremer OL; MARS consortium. Predicting the clinical trajectory in critically ill patients with sepsis: a cohort study. Crit Care. 2019 Dec 12;23(1):408. doi: 10.1186/s13054-019-2687-z.
PubMed 31831072Schouten LRA, Bos LDJ, Serpa Neto A, van Vught LA, Wiewel MA, Hoogendijk AJ, Bonten MJM, Cremer OL, Horn J, van der Poll T, Schultz MJ, Wosten-van Asperen RM; MARS consortium. Increased mortality in elderly patients with acute respiratory distress syndrome is not explained by host response. Intensive Care Med Exp. 2019 Oct 29;7(1):58. doi: 10.1186/s40635-019-0270-1.
PubMed 31664603Verboom DM, Frencken JF, Ong DSY, Horn J, van der Poll T, Bonten MJM, Cremer OL, Klein Klouwenberg PMC. Robustness of sepsis-3 criteria in critically ill patients. J Intensive Care. 2019 Aug 29;7:46. doi: 10.1186/s40560-019-0400-6. eCollection 2019.
PubMed 31489199Frencken JF, van Baal L, Kappen TH, Donker DW, Horn J, van der Poll T, van Klei WA, Bonten MJM, Cremer OL; Members of the MARS Consortium. Myocardial Injury in Critically Ill Patients with Community-acquired Pneumonia. A Cohort Study. Ann Am Thorac Soc. 2019 May;16(5):606-612. doi: 10.1513/AnnalsATS.201804-286OC.
PubMed 30521759Miller RR 3rd, Lopansri BK, Burke JP, Levy M, Opal S, Rothman RE, D'Alessio FR, Sidhaye VK, Aggarwal NR, Balk R, Greenberg JA, Yoder M, Patel G, Gilbert E, Afshar M, Parada JP, Martin GS, Esper AM, Kempker JA, Narasimhan M, Tsegaye A, Hahn S, Mayo P, van der Poll T, Schultz MJ, Scicluna BP, Klein Klouwenberg P, Rapisarda A, Seldon TA, McHugh LC, Yager TD, Cermelli S, Sampson D, Rothwell V, Newman R, Bhide S, Fox BA, Kirk JT, Navalkar K, Davis RF, Brandon RA, Brandon RB. Validation of a Host Response Assay, SeptiCyte LAB, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU. Am J Respir Crit Care Med. 2018 Oct 1;198(7):903-913. doi: 10.1164/rccm.201712-2472OC.
PubMed 29624409Cranendonk DR, van Vught LA, Wiewel MA, Cremer OL, Horn J, Bonten MJ, Schultz MJ, van der Poll T, Wiersinga WJ. Clinical Characteristics and Outcomes of Patients With Cellulitis Requiring Intensive Care. JAMA Dermatol. 2017 Jun 1;153(6):578-582. doi: 10.1001/jamadermatol.2017.0159.
PubMed 28296993
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Diagnosis and Risk Stratification of Sepsis
- ClinicalTrials.gov ID
- NCT01905033
- Acronym / sponsor ID
- MARS / 10-056
- Conditions
- Sepsis
- Keywords
- Sepsis, Pneumonia, Peritonitis, Biomarkers, Transcriptomics, Pathogen detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Center for Translational Molecular Medicine, UMC Utrecht, Radboud University Medical Center, Philips Healthcare, Microbiome, Immunetrics, Check-Points, Biocartis NV, Immunexpress
- Study start
- Jan 2011
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients> 18 years in the Intensive Care Units of the AMC Amsterdam and UMC Utrecht.
Key exclusion criteria (1 listed)
- Elective cardiac surgery patients with an uncomplicated stay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Molecular information about causative pathogens and the host response in patients with sepsis
Time frame: One year
1 secondary outcome
Stratification of septic patients by severity and type of immune response to infection
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Derived from this study: PubMed 41028542Scicluna BP, Cano-Gamez K, Burnham KL, Davenport EE, Moore AR, Khan S, Hinds CJ, Cremer OL, Khatri P, Sweeney TE, Knight JC, van der Poll T. A consensus blood transcriptomic framework for sepsis. Nat Med. 2025 Dec;31(12):4119-4130. doi: 10.1038/s41591-025-03964-5. Epub 2025 Sep 30.
- Derived from this study: PubMed 40390092Filippini DFL, Jiang M, Kramer L, van der Poll T, Cremer O, Hla TTW, Retter A, Bos LDJ; MARS consortium. Plasma H3.1 nucleosomes as biomarkers of infection, inflammation and organ failure. Crit Care. 2025 May 19;29(1):198. doi: 10.1186/s13054-025-05415-6.
- Derived from this study: PubMed 35877767Brands X, Uhel F, van Vught LA, Wiewel MA, Hoogendijk AJ, Lutter R, Schultz MJ, Scicluna BP, van der Poll T. Immune suppression is associated with enhanced systemic inflammatory, endothelial and procoagulant responses in critically ill patients. PLoS One. 2022 Jul 25;17(7):e0271637. doi: 10.1371/journal.pone.0271637. eCollection 2022.
- Derived from this study: PubMed 34902047Peters-Sengers H, Butler JM, Uhel F, Schultz MJ, Bonten MJ, Cremer OL, Scicluna BP, van Vught LA, van der Poll T; MARS consortium. Source-specific host response and outcomes in critically ill patients with sepsis: a prospective cohort study. Intensive Care Med. 2022 Jan;48(1):92-102. doi: 10.1007/s00134-021-06574-0. Epub 2021 Dec 13.
- Derived from this study: PubMed 34784496Frencken JF, van Smeden M, van de Groep K, Ong DSY, Klein Klouwenberg PMC, Juffermans N, Bonten MJM, van der Poll T, Cremer OL; MARS Consortium. Etiology of Myocardial Injury in Critically Ill Patients with Sepsis: A Cohort Study. Ann Am Thorac Soc. 2022 May;19(5):773-780. doi: 10.1513/AnnalsATS.202106-689OC.
- Derived from this study: PubMed 34585271Pereverzeva L, Uhel F, Peters Sengers H, Cremer OL, Schultz MJ, Bonten MMJ, Scicluna BP, van der Poll T; MARS consortium. Association between delay in intensive care unit admission and the host response in patients with community-acquired pneumonia. Ann Intensive Care. 2021 Sep 28;11(1):142. doi: 10.1186/s13613-021-00930-5.
- Derived from this study: PubMed 33935163Brands X, de Vries FMC, Uhel F, Haak BW, Peters-Sengers H, Schuurman AR, van Engelen TSR, Lutter R, Cremer OL, Bonten MJ, Schultz MJ, Scicluna BP, van der Poll T; MARS Consortium. Plasma Ferritin as Marker of Macrophage Activation-Like Syndrome in Critically Ill Patients With Community-Acquired Pneumonia. Crit Care Med. 2021 Nov 1;49(11):1901-1911. doi: 10.1097/CCM.0000000000005072.
- Derived from this study: PubMed 33336322Simonis FD, Schouten LRA, Cremer OL, Ong DSY, Amoruso G, Cinella G, Schultz MJ, Bos LD; MARS consortium. Prognostic classification based on P/F and PEEP in invasively ventilated ICU patients with hypoxemia-insights from the MARS study. Intensive Care Med Exp. 2020 Dec 18;8(Suppl 1):43. doi: 10.1186/s40635-020-00334-y.
- Derived from this study: PubMed 32514599Uhel F, Peters-Sengers H, Falahi F, Scicluna BP, van Vught LA, Bonten MJ, Cremer OL, Schultz MJ, van der Poll T; MARS consortium. Mortality and host response aberrations associated with transient and persistent acute kidney injury in critically ill patients with sepsis: a prospective cohort study. Intensive Care Med. 2020 Aug;46(8):1576-1589. doi: 10.1007/s00134-020-06119-x. Epub 2020 Jun 8.
- Derived from this study: PubMed 31831072Klein Klouwenberg PMC, Spitoni C, van der Poll T, Bonten MJ, Cremer OL; MARS consortium. Predicting the clinical trajectory in critically ill patients with sepsis: a cohort study. Crit Care. 2019 Dec 12;23(1):408. doi: 10.1186/s13054-019-2687-z.
- Derived from this study: PubMed 31664603Schouten LRA, Bos LDJ, Serpa Neto A, van Vught LA, Wiewel MA, Hoogendijk AJ, Bonten MJM, Cremer OL, Horn J, van der Poll T, Schultz MJ, Wosten-van Asperen RM; MARS consortium. Increased mortality in elderly patients with acute respiratory distress syndrome is not explained by host response. Intensive Care Med Exp. 2019 Oct 29;7(1):58. doi: 10.1186/s40635-019-0270-1.
- Derived from this study: PubMed 31489199Verboom DM, Frencken JF, Ong DSY, Horn J, van der Poll T, Bonten MJM, Cremer OL, Klein Klouwenberg PMC. Robustness of sepsis-3 criteria in critically ill patients. J Intensive Care. 2019 Aug 29;7:46. doi: 10.1186/s40560-019-0400-6. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom van der Poll, Prof. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom van der Poll, Prof. (+31205665910, t.vanderpoll@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular information about causative pathogens and the host response in patients with sepsis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01905033, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.