SepsisPre-SEPSISNCT04189549
Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness
An observational study of Sepsis, run by Robert Ehrman at 5 sites in United States.
Trial summary
This clinical study is to evaluate a novel biomarker - CNA Rapid Sepsis Dx - to predict the development of sepsis in patients admitted to the hospital with non-sepsis conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- CNA Rapid Sepsis Dx
- How many people
- 2,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Dec 2019to 30 Apr 2021
- 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: Patients presenting to the hospital and admitted for non-sepsis conditions who are at increased risk for developing sepsis per Sepsis-3 criteria within the hospital.
Who may be able to join
- Patient 18 years of age or older at the time of enrollment
- Presence of any of the following high-risk features:
- Victims of trauma with either an Injury Severity Score of ≥ 15 or a Glasgow Coma Score of ≤ 8[2] OR
- Any patient undergoing high-risk surgical procedures including any emergency surgery and high risk elective surgery procedures involving the thorax, esophagus, stomach, small bowel, large bowel [3, 4] OR
- Any patient being admitted to any ICU setting for any reason with no current evidence or suspicion of active infection (by primary team).[5, 6]
- Able to collect sample within 24 hours of presentation to the hospital.
Who cannot join
- Prisoners or in police custody
- Pregnancy
- Pre-existing infection for which patient is being treated with antibiotics as an outpatient.
- Plan for ongoing antibiotic therapy by treating team (up to three doses antibiotics for peri-procedure prophylaxis is allowable).
- Moribund, unlikely to survive the duration of active enrollment
- Comfort care measures in place or ordered at time of screening OR indication from treating team that active medical care will not be pursued due to patient's condition or patient's/family's wishes.
- Palliative care or hospice consult at time of screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama Birmingham
Birmingham, Alabama, 35233
Alyssa Kirkman, 205-934-5890, akirkman@uabmc.edu
Jan Jansen, MBBS, PhD
Detroit Receiving Hospital
Detroit, Michigan, 48201
Samuel Ceckowski, 313-966-9265, sceckows@med.wayne.edu
Robert Ehrman, MD
Harper University Hospital
Detroit, Michigan, 48201
Samuel Ceckowski, 313-966-9265, sceckows@med.wayne.edu
Sinai-Grace Hospital
Detroit, Michigan, 48235
Thomas Mazzocco, 313-966-1829, tmazzocco@wayne.edu
Robert Ehrman, MD
Northwell Health
New York, New York, 11042
Ramona Ramdeo, 516-465-5400, rramdeo@northwell.edu
Mangala Narasimhan, DO
About this study
Official title: Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness (Pre-SEPSIS Trial)
This clinical study is to evaluate a novel biomarker - CNA Rapid Sepsis Dx - to predict the development of sepsis in patients admitted to the hospital with non-sepsis conditions. Using circulating cell-free DNA (cfDNA) in the blood stream, it has been demonstrated to detect infection response days before clinical evidence of sepsis manifests. The hypothesis is that blood biomarkers drawn daily in the hospital will identify patients who develop sepsis within seven days of hospital presentation.
Read the detailed description
This is a prospective observational trial evaluating CNA Rapid Sepsis Dx -novel biomarkers (CNA Diagnostics Inc.; Calgary, Canada) based on circulating cell-free DNA (cfDNA) in the blood stream to identify patients originally admitted with non-sepsis conditions who ultimately develop sepsis according to Sepsis-3 criteria within seven days of hospital presentation. This novel technology has been demonstrated to detect host-related response to infection days before clinical evidence of sepsis manifests.
The primary objective of this study is to assess the performance of the novel diagnostic assay, CNA Rapid Sepsis Dx, based on the biomarkers, drawn daily from the day of hospital presentation, to identify patients who ultimately develop sepsis according to Sepsis-3-definition within seven days of hospital presentation.
The secondary objective is to correlate the CNA Rapid Sepsis Dx with clinically relevant outcomes such as infections that otherwise do not meet Sepsis-3 criteria, intensive care unit (ICU) length of stay, hospital length of stay, fluid culture results, and hospital mortality.
- Conditions
- Sepsis
- Being tested
- CNA Rapid Sepsis Dx
- Keywords
- Biomarker, Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNA Rapid Sepsis DxDiagnostic test
Novel biomarker based on circulating cell-free DNA (cfDNA) in the human blood stream
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical development of sepsis
Sepsis determined according to Sepsis-3 definition
Measured: Seven Days from hospital presentation
Secondary outcomes (5)
SIRS sepsis
Infection with systemic inflammatory response syndrome (SIRS) criteria
Measured: Seven Days from hospital presentation
Hospital Length of Stay
Duration of hospital stay in survivors and non-survivors from date/time of hospital presentation to order for discharge.
Measured: Up to 12 months
Intensive Care Unit Length of Stay
Duration of ICU stay in survivors and non-survivors from date/time of ICU admission to date/time order for transfer / discharge from ICU.
Measured: Up to 6 months
Development of non-Sepsis 3 Infections
An infection is suspected (by any degree of confidence) but the subject does not meet criteria for either Sepsis-3 or SIRS sepsis.
Measured: Seven Days from hospital presentation
Body Fluid Culture Results
All fluid culture results (blood, CSF, urine, synovial, ascitic, abscess, etc) collected during the study period will be recorded
Measured: Seven Days from hospital presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start9 Dec 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Ehrman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Ehrman, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189549
- Sponsor's protocol ID
- 2019R110
- Acronym
- Pre-SEPSIS
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness (Pre-SEPSIS Trial)
- ClinicalTrials.gov ID
- NCT04189549
- Acronym / sponsor ID
- Pre-SEPSIS / 2019R110
- Conditions
- Sepsis
- Keywords
- Biomarker, Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Robert EhrmanUniversity, hospital or other
- Study start
- 9 Dec 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 6 Dec 2019 (actual)
- 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.
This clinical study is to evaluate a novel biomarker - CNA Rapid Sepsis Dx - to predict the development of sepsis in patients admitted to the hospital with non-sepsis conditions. Using circulating cell-free DNA (cfDNA) in the blood stream, it has been demonstrated to detect infection response days before clinical evidence of sepsis manifests. The hypothesis is that blood biomarkers drawn daily in the hospital will identify patients who develop sepsis within seven days of hospital presentation.
Detailed description
This is a prospective observational trial evaluating CNA Rapid Sepsis Dx -novel biomarkers (CNA Diagnostics Inc.; Calgary, Canada) based on circulating cell-free DNA (cfDNA) in the blood stream to identify patients originally admitted with non-sepsis conditions who ultimately develop sepsis according to Sepsis-3 criteria within seven days of hospital presentation. This novel technology has been demonstrated to detect host-related response to infection days before clinical evidence of sepsis manifests.
The primary objective of this study is to assess the performance of the novel diagnostic assay, CNA Rapid Sepsis Dx, based on the biomarkers, drawn daily from the day of hospital presentation, to identify patients who ultimately develop sepsis according to Sepsis-3-definition within seven days of hospital presentation.
The secondary objective is to correlate the CNA Rapid Sepsis Dx with clinically relevant outcomes such as infections that otherwise do not meet Sepsis-3 criteria, intensive care unit (ICU) length of stay, hospital length of stay, fluid culture results, and hospital mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the hospital and admitted for non-sepsis conditions who are at increased risk for developing sepsis per Sepsis-3 criteria within the hospital.
Key inclusion criteria (6 listed)
- Patient 18 years of age or older at the time of enrollment
- Presence of any of the following high-risk features:
- Able to collect sample within 24 hours of presentation to the hospital.
Key exclusion criteria (7 listed)
- Prisoners or in police custody
- Pregnancy
- Pre-existing infection for which patient is being treated with antibiotics as an outpatient.
- Plan for ongoing antibiotic therapy by treating team (up to three doses antibiotics for peri-procedure prophylaxis is allowable).
- Moribund, unlikely to survive the duration of active enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNA Rapid Sepsis DxNovel biomarker based on circulating cell-free DNA (cfDNA) in the human blood stream | Diagnostic test | – |
Primary outcome
Clinical development of sepsis
Time frame: Seven Days from hospital presentation
Sepsis determined according to Sepsis-3 definition
5 secondary outcomes
SIRS sepsis
Time frame: Seven Days from hospital presentation
Hospital Length of Stay
Time frame: Up to 12 months
Intensive Care Unit Length of Stay
Time frame: Up to 6 months
Development of non-Sepsis 3 Infections
Time frame: Seven Days from hospital presentation
Body Fluid Culture Results
Time frame: Seven Days from hospital presentation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
5 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 Robert Ehrman at 5 sites in United States.
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 6 inclusion and 7 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 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 Patrick Medado (3135777500, pmedado@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical development of sepsis (time frame: Seven Days from hospital presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2019.