Collection of Clinical Specimens From Volunteers for Assay Development

NCT ID: NCT03606382

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-05-01

Brief Summary

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This study will analyze gene expression data from various biological specimens collected from voluntary participants.

Detailed Description

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Primary objective is the collection of specimens from volunteers for the development and validation of HostDx tests. The study does only encompass specimen collection - Therefore, no traditional endpoint is defined but rather the successful collection of clinical specimens is defined as the endpoint.

Conditions

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Acute Respiratory Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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HostDx Fever Test

HostDx Fever test to distinguish between viral and bacterial infections

Intervention Type DIAGNOSTIC_TEST

HostDx Sepsis Test

HostDx Fever test to determine the severity of a presented, suspected infection.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or greater
* Able to provide informed consent

Exclusion Criteria

* Known pregnancy
* Inability to understand instructions and comply with study related procedures
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inflammatix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Inflammatix, Inc.

Burlingame, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20048677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24717459 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 23411577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26903338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22851117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25972003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27384347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29449546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27681387 (View on PubMed)

Other Identifiers

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DEV-INF-01

Identifier Type: -

Identifier Source: org_study_id

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