Collection of Clinical Specimens From Volunteers for Assay Development

Acute Respiratory Infection Clinical Trial

Official title:

Collection of Clinical Specimens From Volunteers for Assay Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606382
• Other study ID #: DEV-INF-01
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: September 2019
• Source: Inflammatix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Respiratory Tract Infections

Intervention

Diagnostic Test:
• HostDx Fever Test
HostDx Fever test to distinguish between viral and bacterial infections
• HostDx Sepsis Test
HostDx Fever test to determine the severity of a presented, suspected infection.

Locations

Country	Name	City	State
United States	Inflammatix, Inc.	Burlingame	California

Sponsors (1)

Lead Sponsor	Collaborator
Inflammatix

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Review. 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

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. Review. — View Citation

Sweeney TE, Khatri P. Benchmarking Sepsis Gene Expression Diagnostics Using Public Data. Crit Care Med. 2017 Jan;45(1):1-10. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of Specimens from Volunteers for the Development and Validation of HostDx Tests	Blood collection, upper respiratory specimens including. nasal swabs, nasal washes, nasopharyngeal swabs, buccal swabs, buccal washes), sputum, saliva, urine and a skin/soft-tissue specimen (dermal).	1 Day