SepsisNEPTUNENCT05469048
Near Patient Molecular Testing in Sepsis
An observational study of Sepsis and Systemic Inflammatory Response Syndrome, run by Immunexpress at 3 sites in United States.
Trial summary
The purpose of the study is to evaluate the real-time performance of a new host response test (SeptiCyte RAPID) for differentiating sepsis from non-infection/systemic inflammatory response syndrome among patients suspected of sepsis within the first 24 hours of intensive care unit (ICU) admission. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Sepsis, Systemic Inflammatory Response Syndrome
- How many people
- 63 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Mar 2020to 31 Oct 2022
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suspected of sepsis, admitted to an Intensive Care Unit
Who may be able to join
- ≥18 years old on the date of ICU admission
- Systemic Inflammatory Response Syndrome (SIRS) present, as defined by the presence of two or more of the following:
- Temperature > 38°C or < 36°C
- Heart Rate > 90 beat/min
- Tachypnea > 20/min or PaCO2 < 32 mmHg
- WBC count > 12 000/mm3 or < 4 000/mm3 or > 10% immature neutrophils (bands)
- Consent to study inclusion, either by patient or legal surrogate before study-related sample processing
- Study sample collection within 24 hours of ICU admission order
Who cannot join
- Age less than 18 years old on the day of ICU admission
- No order to admit to ICU
- Not physically admitted to ICU
- Commencement of non-prophylactic antibiotics ≥ 24 hours prior to ICU admission
- Study sample collection > 24 hours from ICU admission order
- No clinical cultures or serologic tests obtained when sepsis was suspected
- Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours
- Transfer from another ICU where subject was admitted for ≥ 24 hours.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Rush University Medical Center
Chicago, Illinois, 60612
Keck Hospital of University of Southern California (USC) and Los Angeles County and USC Medical Center
Los Angeles, California, 90033
About this study
The purpose of the study is to evaluate the real-time performance of a new host response test (SeptiCyte RAPID) for differentiating sepsis from non-infection/systemic inflammatory response syndrome among patients suspected of sepsis within the first 24 hours of intensive care unit (ICU) admission.
Read the detailed description
The ability of SeptiCyte RAPID to differentiate sepsis from infection-negative systemic inflammation will be determined using retrospective physician diagnosis performed by an external panel of three physicians not involved with the care of the patients.
- Conditions
- Sepsis, Systemic Inflammatory Response Syndrome
- Medical subject headings
- Sepsis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients sepsis suspected | Patients suspected of sepsis and admitted to ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time evaluation of the diagnostic accuracy of SeptiCyte RAPID in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.
Percentage of correctly identified patients with sepsis or non-infectious systemic inflammation using SeptiCyte RAPID compared to clinical assessments using routine clinical, laboratory, and other findings.
Measured: Time for enrollment, process samples, and collect data, an average of 1 year
Secondary outcomes (1)
Comparison of diagnostic accuracy between SeptiCyte RAPID and up to 15 other clinical parameters in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.
Multi-parametric model to compare diagnostic accuracy between SeptiCyte RAPID alone or in combination with up to 15 other clinical parameters.
Measured: Time for enrollment, process samples, and collect data, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start12 Mar 2020
- Primary completion31 May 2021
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunexpress
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center, Grady Memorial Hospital, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Roy Davis, MD, PhD, MHA, Study director, Immunexpress
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469048
- Sponsor's protocol ID
- NEPTUNE IXP-181
- Acronym
- NEPTUNE
- Status last verified
- Sep 2024
- First submitted
- 15 Jul 2022
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balk R, Esper AM, Martin GS, Miller RR 3rd, Lopansri BK, Burke JP, Levy M, Opal S, Rothman RE, D'Alessio FR, Sidhaye VK, Aggarwal NR, Greenberg JA, Yoder M, Patel G, Gilbert E, Parada JP, Afshar M, Kempker JA, van der Poll T, Schultz MJ, Scicluna BP, Klein Klouwenberg PMC, Liebler J, Blodget E, Kumar S, Navalkar K, Yager TD, Sampson D, Kirk JT, Cermelli S, Davis RF, Brandon RB. Validation of SeptiCyte RAPID to Discriminate Sepsis from Non-Infectious Systemic Inflammation. J Clin Med. 2024 Feb 20;13(5):1194. doi: 10.3390/jcm13051194.
PubMed 38592057
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Patient Molecular Testing in Sepsis
- ClinicalTrials.gov ID
- NCT05469048
- Acronym / sponsor ID
- NEPTUNE / NEPTUNE IXP-181
- Conditions
- Sepsis, Systemic Inflammatory Response Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- ImmunexpressIndustry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center, Grady Memorial Hospital, University of Southern California
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 21 Jul 2022 (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.
The purpose of the study is to evaluate the real-time performance of a new host response test (SeptiCyte RAPID) for differentiating sepsis from non-infection/systemic inflammatory response syndrome among patients suspected of sepsis within the first 24 hours of intensive care unit (ICU) admission.
Detailed description
The ability of SeptiCyte RAPID to differentiate sepsis from infection-negative systemic inflammation will be determined using retrospective physician diagnosis performed by an external panel of three physicians not involved with the care of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients sepsis suspected | – | –Patients suspected of sepsis and admitted to ICU |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suspected of sepsis, admitted to an Intensive Care Unit
Key inclusion criteria (8 listed)
- ≥18 years old on the date of ICU admission
- Systemic Inflammatory Response Syndrome (SIRS) present, as defined by the presence of two or more of the following:
- Consent to study inclusion, either by patient or legal surrogate before study-related sample processing
- Study sample collection within 24 hours of ICU admission order
Key exclusion criteria (8 listed)
- Age less than 18 years old on the day of ICU admission
- No order to admit to ICU
- Not physically admitted to ICU
- Commencement of non-prophylactic antibiotics ≥ 24 hours prior to ICU admission
- Study sample collection > 24 hours from ICU admission order
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
Real-time evaluation of the diagnostic accuracy of SeptiCyte RAPID in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.
Time frame: Time for enrollment, process samples, and collect data, an average of 1 year
Percentage of correctly identified patients with sepsis or non-infectious systemic inflammation using SeptiCyte RAPID compared to clinical assessments using routine clinical, laboratory, and other findings.
1 secondary outcome
Comparison of diagnostic accuracy between SeptiCyte RAPID and up to 15 other clinical parameters in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU.
Time frame: Time for enrollment, process samples, and collect data, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Results publication: PubMed 38592057Balk R, Esper AM, Martin GS, Miller RR 3rd, Lopansri BK, Burke JP, Levy M, Opal S, Rothman RE, D'Alessio FR, Sidhaye VK, Aggarwal NR, Greenberg JA, Yoder M, Patel G, Gilbert E, Parada JP, Afshar M, Kempker JA, van der Poll T, Schultz MJ, Scicluna BP, Klein Klouwenberg PMC, Liebler J, Blodget E, Kumar S, Navalkar K, Yager TD, Sampson D, Kirk JT, Cermelli S, Davis RF, Brandon RB. Validation of SeptiCyte RAPID to Discriminate Sepsis from Non-Infectious Systemic Inflammation. J Clin Med. 2024 Feb 20;13(5):1194. doi: 10.3390/jcm13051194.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
RecruitingPhase 3
THE ROLE OF PANCREATIC STONE PROTEIN (PSP) AND PSP-GUIDED EARLY MEROPENEM TREATMENT TO MITIGATE SEPSIS RISK AT THE EMERGENCY DEPARTMENT: THE PROMISE DOUBLE BLIND, PHASE III, RANDOMIZED CONTROLLED CLINICAL TRIAL
Sepsis
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
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.
Roy Davis, MD, PhD, MHA study director
Immunexpress
3 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 and Systemic Inflammatory Response Syndrome, run by Immunexpress at 3 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-time evaluation of the diagnostic accuracy of SeptiCyte RAPID in differentiating sepsis from non-infectious systemic inflammation in patients admitted to the ICU. (time frame: Time for enrollment, process samples, and collect data, an average of 1 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 NCT05469048, which also lists 1 linked publication.
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 2 Oct 2024.