SepsisNCT02704871
The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS
An observational study of Sepsis and SIRS, run by Immunexpress at 1 site in United States.
Trial summary
A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from infection-negative SIRS Read more about this study
- Who is it for?
- Ages 18 to 89 years
- What is being tested?
- SeptiCyte Lab molecular diagnostic test (non-interventional)
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Feb 2018
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older, previously admitted to medical and/or surgical general hospital wards, who are suspected of sepsis as identified by an in-hospital early-warning screening tool.
Who may be able to join
- 18-89 years old on the day of enrollment.
- Currently admitted to study designated medical or surgical ward
- Have a clinical suspicion of sepsis as determined by two physicians after identification by hospital screening tool.
- Screened positive for sepsis, severe sepsis or septic shock using the RISE2 screening tool.
- Completed SBAR handover (Situation, Background, Assessment, Recommendation)
- SIRS present as defined by the presence of two or more of the following:
Show all 10Show fewer
- 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)
Who cannot join
- Consent not provided
- Patients less than 18 years of age, or 90 years of age or older.
- Patients for which a blood sample could not be taken within 24 hours of a physician first determining a clinical suspicion of sepsis.
- Patients that are not located in the designated medical or surgical ward associated with the study.
- Patients listed for "Comfort Measures Only".
- Less than 2 SIRS criteria
- Commencement of narrow spectrum directed antibiotics prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: To Assess the Performance of SeptiCyte® Lab to Diagnose Patients Identified as Suspected of Sepsis in General Medical and Surgical Wards With Infection-positive From Infection-negative SIRS
A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from infection-negative SIRS
Read the detailed description
This study is evaluating a molecular diagnostic device developed to distinguish between sepsis and infection-negative SIRS among critically ill patients.
This study is a prospective, non-randomized, non-interventional, observational trial of patients with suspected sepsis in the medical and/or surgical wards. The study is being conducted on two preselected patient care units.
All patients identified by a local screening tool undergo physician review. If the suspicion of sepsis is found to be plausible, routine and conventional diagnostic procedures, including: routine bloods, blood culture and specialized tests are conducted.
Blood collection for SeptiCyte® Lab and SeptID® is drawn within 6 hours of a positive screen - both use peripheral blood as the clinical sample. The diagnostic performance of the two experimental assays will be compared to Retrospective Physician Diagnosis (RPD), and conventional microbiological culture. The results of SeptiCyte® Lab and SeptID® are not used in any clinical decision-making.
This data will be used to analyze the performance of SeptiCyte® Lab according to the endpoint measures.
- Being tested
- SeptiCyte Lab molecular diagnostic test (non-interventional)
- Keywords
- SeptiCyte
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeptiCyte Lab molecular diagnostic test (non-interventional)Other
This is not an interventional study. Rather it involves evaluation of a molecular diagnostic test to distinguish between sepsis and infection-negative SIRS based on host response.
What is being measured
The primary outcome is the main question the study is designed to answer.
SeptiCyte® Lab test result versus Retrospective Physician Diagnosis (RPD) result
To validate the ability of the SeptiCyte® Lab test to correctly discriminate infection positive from infection negative SIRS in hospital ward patients with two or more SIRS criteria compared to the non-reference method of retrospective physician diagnosis (RPD).
Measured: 7 days
Secondary outcomes (1)
SeptiCyte® Lab test result versus test results for other sepsis biomarkes, including leukocytosis, bandemia, & procalcitonin
To compare SeptiCyte® Lab test scores with other clinical sepsis biomarkers to assess its ability to discriminate infection positive from infection negative SIRS.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionFeb 2018
Why it stopped: Recruitment considerations only and not because of safety or outcomes issues
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
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunexpress
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rhode Island Hospital
- Responsible party
- Sponsor
- Investigators
- Mitchell Levy, MD, Principal investigator, Rhode Island HospitalSteven Opal, MD, Principal investigator, Memorial Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704871
- Sponsor's protocol ID
- IXP 04-01b
- Status last verified
- Feb 2018
- First submitted
- 2 Mar 2016
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Performance of SeptiCyte® Lab to Diagnose Patients Identified as Suspected of Sepsis in General Medical and Surgical Wards With Infection-positive From Infection-negative SIRS
- ClinicalTrials.gov ID
- NCT02704871
- Acronym / sponsor ID
- IXP 04-01b
- Keywords
- SeptiCyte
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment considerations only and not because of safety or outcomes issues
- Enrolment
- 66 participants (actual)
- Lead sponsor
- ImmunexpressIndustry (pharma, biotech, devices)
- Collaborators
- Rhode Island Hospital
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 10 Mar 2016 (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.
A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from infection-negative SIRS
Detailed description
This study is evaluating a molecular diagnostic device developed to distinguish between sepsis and infection-negative SIRS among critically ill patients.
This study is a prospective, non-randomized, non-interventional, observational trial of patients with suspected sepsis in the medical and/or surgical wards. The study is being conducted on two preselected patient care units.
All patients identified by a local screening tool undergo physician review. If the suspicion of sepsis is found to be plausible, routine and conventional diagnostic procedures, including: routine bloods, blood culture and specialized tests are conducted.
Blood collection for SeptiCyte® Lab and SeptID® is drawn within 6 hours of a positive screen - both use peripheral blood as the clinical sample. The diagnostic performance of the two experimental assays will be compared to Retrospective Physician Diagnosis (RPD), and conventional microbiological culture. The results of SeptiCyte® Lab and SeptID® are not used in any clinical decision-making.
This data will be used to analyze the performance of SeptiCyte® Lab according to the endpoint measures.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older, previously admitted to medical and/or surgical general hospital wards, who are suspected of sepsis as identified by an in-hospital early-warning screening tool.
Key inclusion criteria (10 listed)
- 18-89 years old on the day of enrollment.
- Currently admitted to study designated medical or surgical ward
- Have a clinical suspicion of sepsis as determined by two physicians after identification by hospital screening tool.
- Screened positive for sepsis, severe sepsis or septic shock using the RISE2 screening tool.
- Completed SBAR handover (Situation, Background, Assessment, Recommendation)
Key exclusion criteria (7 listed)
- Consent not provided
- Patients less than 18 years of age, or 90 years of age or older.
- Patients for which a blood sample could not be taken within 24 hours of a physician first determining a clinical suspicion of sepsis.
- Patients that are not located in the designated medical or surgical ward associated with the study.
- Patients listed for "Comfort Measures Only".
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 |
|---|---|---|
| SeptiCyte Lab molecular diagnostic test (non-interventional)This is not an interventional study. Rather it involves evaluation of a molecular diagnostic test to distinguish between sepsis and infection-negative SIRS based on host response. | Other | – |
Primary outcome
SeptiCyte® Lab test result versus Retrospective Physician Diagnosis (RPD) result
Time frame: 7 days
To validate the ability of the SeptiCyte® Lab test to correctly discriminate infection positive from infection negative SIRS in hospital ward patients with two or more SIRS criteria compared to the non-reference method of retrospective physician diagnosis (RPD).
1 secondary outcome
SeptiCyte® Lab test result versus test results for other sepsis biomarkes, including leukocytosis, bandemia, & procalcitonin
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Recruitment considerations only and not because of safety or outcomes issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
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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.
Mitchell Levy, MD principal investigator
Rhode Island Hospital
Steven Opal, MD principal investigator
Memorial Hospital of Rhode Island
1 site 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 SIRS, run by Immunexpress at 1 site 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 10 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: stopped early, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Recruitment considerations only and not because of safety or outcomes issues). Results are not available in the source record.
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?
SeptiCyte® Lab test result versus Retrospective Physician Diagnosis (RPD) result (time frame: 7 days). 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 1 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.