Respiratory Tract InfectionsSEPSIS-SHIELDNCT04094818
TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis
An observational study of Respiratory Tract Infections and Urinary Tract Infections, run by Inflammatix at 26 sites in 2 countries.
Trial summary
This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin \& soft tissue infections; or suspected sepsis of any cause. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections
- What is being tested?
- TriVerity
- How many people
- 1,441 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 28 Feb 2020to 30 Sep 2024
- 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 emergency departments of enrolling sites with: 1. Suspected infection and one or more abnormal vital signs, OR 2. Patients with suspected sepsis of any cause as defined by a blood culture order by the treating physician and two or more abnormal vital signs
Who may be able to join
- Age >18 year
- Suspected acute infection (respiratory, urinary, abdominal, skin \& soft-tissue), and at least one of the symptoms OR, Suspected sepsis of any cause as defined by a blood culture order by the treating physician, and at least two of the symptoms:
- Heart rate: >90 beats/ minute
- Temperature: >38 C or <36C
- Respiratory Rate: >20 breaths / minutes or PaO2 of <60 mmHg or SpO2 <90%
- Systolic blood pressure: <100 mmHg
- Altered mental status: Per clinical exam
- Able to provide informed consent, or consent by legally authorized representative.
Who cannot join
- Participants will be ineligible for this study if they meet any of the following criteria:
- Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the emergency department study visit. Participants will not be excluded for use of:
- Antiviral treatment for HIV infection and hepatitis B and hepatitis C
- Topical antibiotics, topical antiviral or topical antifungal agents
- Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
- Peri-operative (prophylactic) antibiotics
Show all 12Show fewer
- A single dose of antimicrobials during the present ED visit (<10h before blood draw); note single dose can be considered mono or combination therapy, wherein combination is administered as part of local Standard of Care and only one dose of each medication is administered within the allowable 10-hour window
- Patients receiving palliative or hospice care, or those receiving limited interventional care.
- Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient.
- Patients receiving experimental therapy or already enrolled in an interventional clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs, medical devices, or vaccines.
- Subjects that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial.
- Patients previously enrolled in the present clinical trial.
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
Emory University
Atlanta, Georgia, 30303
Johns Hopkins Hospital
Baltimore, Maryland, 21209
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
Geisinger Health
Danville, Pennsylvania, 17822
Henry Ford Hospital
Detroit, Michigan, 48202
Essentia Institute of Rural Health
Duluth, Minnesota, 55805
Texas Tech University Health Sciences Center - El Paso
El Paso, Texas, 79905
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Florida (UF) - Jacksonville
Jacksonville, Florida, 32209
University of Kentucky
Lexington, Kentucky, 40536
University of Southern California
Los Angeles, California, 90033
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of South Alabama
Mobile, Alabama, 36617
Hackensack Meridian Health
Montclair, New Jersey, 07042
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Oklahoma University Health
Oklahoma City, Oklahoma, 73104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Mayo Clinic
Rochester, Minnesota, 55905
University of California Davis Medical Center
Sacramento, California, 95817
Baystate Medical Center
Springfield, Massachusetts, 01199
Washington University
St Louis, Missouri, 63110
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010
About this study
This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin \& soft tissue infections; or suspected sepsis of any cause.
- Conditions
- Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections, Skin and Soft Tissue Infection, Suspected Meningitis/Encephalitis or Any Other Infection, Sepsis
- Being tested
- TriVerity
- Keywords
- Infection, mRNA, Procalcitonin, C-Reactive Protein, Lactate
- Medical subject headings
- Respiratory Tract Infections, Urinary Tract Infections, Intraabdominal Infections, Soft Tissue Infections, Encephalitis, Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriVerityDiagnostic test
Also called InSep, HostDx Sepsis
Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection and sputum/ BAL sample collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the diagnostic performance of HostDx Sepsis
Concordance of HostDx Sepsis bacterial readout with clinical adjudication
Measured: 28 Days After Enrollment
Evaluation of the diagnostic performance of HostDx Sepsis
Concordance of HostDx Sepsis viral readout with clinical adjudication
Measured: 28 Days After Enrollment
Evaluation of the prognostic performance of HostDx Sepsis
Concordance of HostDx Sepsis severity readout with receipt of ICU-level care (including requirement for ICU transfer, mechanical ventilation, vasopressors, or renal replacement therapy (RRT))
Measured: 7 Days After Enrollment
Secondary outcomes (2)
Evaluation of the prognostic performance of HostDx Sepsis
Concordance of HostDx Sepsis severity readout with receipt of ICU-level care (including requirement for ICU transfer, mechanical ventilation, vasopressors, or renal replacement therapy (RRT)) within 7 days OR 28-Day Hospital Mortality
Measured: 28 Days after enrollment
Evaluation of the prognostic performance of HostDx Sepsis for 28-Day Hospital Mortality
Concordance of HostDx Sepsis severity readout with 28-Day Hospital Mortality
Measured: 28 Days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start28 Feb 2020
- Primary completion6 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflammatix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094818
- Sponsor's protocol ID
- INF-04
- Acronym
- SEPSIS-SHIELD
- Status last verified
- Oct 2024
- First submitted
- 17 Sep 2019
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaieski DF, Mikkelsen ME, Band RA, Pines JM, Massone R, Furia FF, Shofer FS, Goyal M. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med. 2010 Apr;38(4):1045-53. doi: 10.1097/CCM.0b013e3181cc4824.
PubMed 20048677Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. doi: 10.1097/CCM.0000000000000330.
PubMed 24717459Mi MY, Klompas M, Evans L. Early Administration of Antibiotics for Suspected Sepsis. N Engl J Med. 2019 Feb 7;380(6):593-596. doi: 10.1056/NEJMclde1809210. No abstract available.
PubMed 30726686Singer M. Biomarkers in sepsis. Curr Opin Pulm Med. 2013 May;19(3):305-9. doi: 10.1097/MCP.0b013e32835f1b49.
PubMed 23411577Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Coburn B, Morris AM, Tomlinson G, Detsky AS. Does this adult patient with suspected bacteremia require blood cultures? JAMA. 2012 Aug 1;308(5):502-11. doi: 10.1001/jama.2012.8262.
PubMed 22851117Gunsolus IL, Sweeney TE, Liesenfeld O, Ledeboer NA. Diagnosing and Managing Sepsis by Probing the Host Response to Infection: Advances, Opportunities, and Challenges. J Clin Microbiol. 2019 Jun 25;57(7):e00425-19. doi: 10.1128/JCM.00425-19. Print 2019 Jul.
PubMed 31043466Sweeney TE, Shidham A, Wong HR, Khatri P. A comprehensive time-course-based multicohort analysis of sepsis and sterile inflammation reveals a robust diagnostic gene set. Sci Transl Med. 2015 May 13;7(287):287ra71. doi: 10.1126/scitranslmed.aaa5993.
PubMed 25972003Sweeney TE, Wong HR, Khatri P. Robust classification of bacterial and viral infections via integrated host gene expression diagnostics. Sci Transl Med. 2016 Jul 6;8(346):346ra91. doi: 10.1126/scitranslmed.aaf7165.
PubMed 27384347Sweeney TE, Perumal TM, Henao R, Nichols M, Howrylak JA, Choi AM, Bermejo-Martin JF, Almansa R, Tamayo E, Davenport EE, Burnham KL, Hinds CJ, Knight JC, Woods CW, Kingsmore SF, Ginsburg GS, Wong HR, Parnell GP, Tang B, Moldawer LL, Moore FE, Omberg L, Khatri P, Tsalik EL, Mangravite LM, Langley RJ. A community approach to mortality prediction in sepsis via gene expression analysis. Nat Commun. 2018 Feb 15;9(1):694. doi: 10.1038/s41467-018-03078-2.
PubMed 29449546Sweeney TE, Khatri P. Benchmarking Sepsis Gene Expression Diagnostics Using Public Data. Crit Care Med. 2017 Jan;45(1):1-10. doi: 10.1097/CCM.0000000000002021.
PubMed 27681387Whitfield NN, Hogan CA, Chenoweth J, Hansen J, Hsu EB, Humphries R, Mann E, May L, Michelson EA, Rothman R, Self WH, Smithline HA, Karita HCS, Steingrub JS, Swedien D, Weissman A, Wright DW, Liesenfeld O, Shapiro NI. A standardized protocol using clinical adjudication to define true infection status in patients presenting to the emergency department with suspected infections and/or sepsis. Diagn Microbiol Infect Dis. 2024 Sep;110(1):116382. doi: 10.1016/j.diagmicrobio.2024.116382. Epub 2024 May 31.
PubMed 38850687
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis
- ClinicalTrials.gov ID
- NCT04094818
- Acronym / sponsor ID
- SEPSIS-SHIELD / INF-04
- Conditions
- Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections, Skin and Soft Tissue Infection, Suspected Meningitis/Encephalitis or Any Other Infection, Sepsis
- Keywords
- Infection, mRNA, Procalcitonin, C-Reactive Protein, Lactate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,441 participants (actual)
- Lead sponsor
- InflammatixIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 19 Sep 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 study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin \& soft tissue infections; or suspected sepsis of any cause.
Study design
- Observational model
- Case-control
- 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 emergency departments of enrolling sites with: 1. Suspected infection and one or more abnormal vital signs, OR 2. Patients with suspected sepsis of any cause as defined by a blood culture order by the treating physician and two or more abnormal vital signs
Key inclusion criteria (8 listed)
- Age >18 year
- Suspected acute infection (respiratory, urinary, abdominal, skin \& soft-tissue), and at least one of the symptoms OR, Suspected sepsis of any cause as defined by a blood culture order by the treating physician, and at least two of the symptoms:
- Able to provide informed consent, or consent by legally authorized representative.
Key exclusion criteria (12 listed)
- Participants will be ineligible for this study if they meet any of the following criteria:
- Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the emergency department study visit. Participants will not be excluded for use of:
- Patients receiving palliative or hospice care, or those receiving limited interventional care.
- Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient.
- Patients receiving experimental therapy or already enrolled in an interventional clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs, medical devices, or vaccines.
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 |
|---|---|---|
| TriVerityAlso: InSep, HostDx SepsisBlood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection and sputum/ BAL sample collection | Diagnostic test | – |
Primary outcome
Evaluation of the diagnostic performance of HostDx Sepsis
Time frame: 28 Days After Enrollment
Concordance of HostDx Sepsis bacterial readout with clinical adjudication
Evaluation of the diagnostic performance of HostDx Sepsis
Time frame: 28 Days After Enrollment
Concordance of HostDx Sepsis viral readout with clinical adjudication
Evaluation of the prognostic performance of HostDx Sepsis
Time frame: 7 Days After Enrollment
Concordance of HostDx Sepsis severity readout with receipt of ICU-level care (including requirement for ICU transfer, mechanical ventilation, vasopressors, or renal replacement therapy (RRT))
2 secondary outcomes
Evaluation of the prognostic performance of HostDx Sepsis
Time frame: 28 Days after enrollment
Evaluation of the prognostic performance of HostDx Sepsis for 28-Day Hospital Mortality
Time frame: 28 Days after enrollment
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 22 Oct 2024.
- Background: PubMed 20048677Gaieski DF, Mikkelsen ME, Band RA, Pines JM, Massone R, Furia FF, Shofer FS, Goyal M. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med. 2010 Apr;38(4):1045-53. doi: 10.1097/CCM.0b013e3181cc4824.
- Background: PubMed 24717459Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. doi: 10.1097/CCM.0000000000000330.
- Background: PubMed 30726686Mi MY, Klompas M, Evans L. Early Administration of Antibiotics for Suspected Sepsis. N Engl J Med. 2019 Feb 7;380(6):593-596. doi: 10.1056/NEJMclde1809210. No abstract available.
- Background: PubMed 23411577Singer M. Biomarkers in sepsis. Curr Opin Pulm Med. 2013 May;19(3):305-9. doi: 10.1097/MCP.0b013e32835f1b49.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 22851117Coburn B, Morris AM, Tomlinson G, Detsky AS. Does this adult patient with suspected bacteremia require blood cultures? JAMA. 2012 Aug 1;308(5):502-11. doi: 10.1001/jama.2012.8262.
- Background: PubMed 31043466Gunsolus IL, Sweeney TE, Liesenfeld O, Ledeboer NA. Diagnosing and Managing Sepsis by Probing the Host Response to Infection: Advances, Opportunities, and Challenges. J Clin Microbiol. 2019 Jun 25;57(7):e00425-19. doi: 10.1128/JCM.00425-19. Print 2019 Jul.
- Background: PubMed 25972003Sweeney TE, Shidham A, Wong HR, Khatri P. A comprehensive time-course-based multicohort analysis of sepsis and sterile inflammation reveals a robust diagnostic gene set. Sci Transl Med. 2015 May 13;7(287):287ra71. doi: 10.1126/scitranslmed.aaa5993.
- Background: PubMed 27384347Sweeney TE, Wong HR, Khatri P. Robust classification of bacterial and viral infections via integrated host gene expression diagnostics. Sci Transl Med. 2016 Jul 6;8(346):346ra91. doi: 10.1126/scitranslmed.aaf7165.
- Background: PubMed 29449546Sweeney TE, Perumal TM, Henao R, Nichols M, Howrylak JA, Choi AM, Bermejo-Martin JF, Almansa R, Tamayo E, Davenport EE, Burnham KL, Hinds CJ, Knight JC, Woods CW, Kingsmore SF, Ginsburg GS, Wong HR, Parnell GP, Tang B, Moldawer LL, Moore FE, Omberg L, Khatri P, Tsalik EL, Mangravite LM, Langley RJ. A community approach to mortality prediction in sepsis via gene expression analysis. Nat Commun. 2018 Feb 15;9(1):694. doi: 10.1038/s41467-018-03078-2.
- Background: PubMed 27681387Sweeney TE, Khatri P. Benchmarking Sepsis Gene Expression Diagnostics Using Public Data. Crit Care Med. 2017 Jan;45(1):1-10. doi: 10.1097/CCM.0000000000002021.
- Derived from this study: PubMed 38850687Whitfield NN, Hogan CA, Chenoweth J, Hansen J, Hsu EB, Humphries R, Mann E, May L, Michelson EA, Rothman R, Self WH, Smithline HA, Karita HCS, Steingrub JS, Swedien D, Weissman A, Wright DW, Liesenfeld O, Shapiro NI. A standardized protocol using clinical adjudication to define true infection status in patients presenting to the emergency department with suspected infections and/or sepsis. Diagn Microbiol Infect Dis. 2024 Sep;110(1):116382. doi: 10.1016/j.diagmicrobio.2024.116382. Epub 2024 May 31.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections and Urinary Tract Infections, run by Inflammatix at 26 sites in 2 countries.
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 12 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 22 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 26 sites in United States, Greece. 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?
Evaluation of the diagnostic performance of HostDx Sepsis (time frame: 28 Days After Enrollment). The study lists 3 primary outcomes in all. 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 NCT04094818, which also lists 12 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 22 Oct 2024.