HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis

Sepsis Clinical Trial

— SEPSIS-SHIELD  

Official title:

HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094818
• Other study ID #: INF-04
• Status: Recruiting
• Start date: February 28, 2020
• Est. completion date: May 15, 2024

Study information

• Verified date: December 2023
• Source: Inflammatix
• Contact: Oliver Liesenfeld, MD
• Phone: (650) 443-3030
• Email: clinicaltrials[@]inflammatix.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: May 15, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >18 year

2. 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

3. Able to provide informed consent, or consent by legally authorized representative.

Exclusion Criteria:

1. 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 the following:

• Use of topical antibiotics, topical antiviral or topical antifungal agents
• Use of peri-operative (prophylactic) antibiotics
• Use of a single dose of antibiotics during the present ED visit (<6h before blood draw).

2. 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.

3. Previously enrolled in the present clinical trial.

Related Conditions & MeSH terms

• Communicable Diseases
• Encephalitis
• Infections
• Intra-Abdominal Infections
• Intraabdominal Infections
• Meningitis
• Respiratory Tract Infections
• Sepsis
• Skin and Soft Tissue Infection
• Soft Tissue Infections
• Toxemia
• Urinary Tract Infections

Intervention

Diagnostic Test:
• HostDx Sepsis
Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection

Locations

Country	Name	City	State
Greece	ATTIKON University Hospital	Athens
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Geisinger Health	Danville	Pennsylvania
United States	Henry Ford Hospital	Detroit	Michigan
United States	Essentia Institute of Rural Health	Duluth	Minnesota
United States	Texas Tech University Health Sciences Center - El Paso	El Paso	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of Florida (UF) - Jacksonville	Jacksonville	Florida
United States	University of Kentucky	Lexington	Kentucky
United States	University of Southern California	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of South Alabama	Mobile	Alabama
United States	Hackensack Meridian Health	Montclair	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Oklahoma University Health	Oklahoma City	Oklahoma
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California Davis Medical Center	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Medstar Health Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Inflammatix

Countries where clinical trial is conducted

United States,  Greece, 

References & Publications (11)

Coburn 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. Erratum In: JAMA. 2013 Jan 23;309(4):343. — View Citation

Ferrer 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. — View Citation

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. — View Citation

Gunsolus 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. — View Citation

Mi 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. — View Citation

Singer 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. — View Citation

Singer M. Biomarkers in sepsis. Curr Opin Pulm Med. 2013 May;19(3):305-9. doi: 10.1097/MCP.0b013e32835f1b49. — View Citation

Sweeney 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. — View Citation

Sweeney 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. — View Citation

Sweeney 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. — View Citation

Sweeney 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the diagnostic performance of HostDx Sepsis	Concordance of HostDx Sepsis bacterial readout with clinical adjudication	28 Days After Enrollment
Primary	Evaluation of the diagnostic performance of HostDx Sepsis	Concordance of HostDx Sepsis viral readout with clinical adjudication	28 Days After Enrollment
Primary	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))	7 Days After Enrollment
Secondary	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	28 Days after enrollment
Secondary	Evaluation of the prognostic performance of HostDx Sepsis for 28-Day Hospital Mortality	Concordance of HostDx Sepsis severity readout with 28-Day Hospital Mortality	28 Days after enrollment