Collection of Clinical Specimens From Volunteers for Assay Development
Sponsor
Inflammatix (Industry)
Overall Status
Completed
CT.gov ID
NCT03606382
Collaborator
(none)
6
1
13
0.5
Study Details
Study Description
Brief Summary
This study will analyze gene expression data from various biological specimens collected from voluntary participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Study Type:
Observational
Actual Enrollment
:
6 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Collection of Clinical Specimens From Volunteers for Assay Development
Actual Study Start Date
:
Apr 1, 2018
Actual Primary Completion Date
:
May 1, 2019
Actual Study Completion Date
:
May 1, 2019
Outcome Measures
Primary Outcome Measures
- Collection of Specimens from Volunteers for the Development and Validation of HostDx Tests [1 Day]
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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inflammatix, Inc. | Burlingame | California | United States | 94010 |
Sponsors and Collaborators
- Inflammatix
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- Singer M. Biomarkers in sepsis. Curr Opin Pulm Med. 2013 May;19(3):305-9. doi: 10.1097/MCP.0b013e32835f1b49. Review.
- Sweeney TE, Khatri P. Benchmarking Sepsis Gene Expression Diagnostics Using Public Data. Crit Care Med. 2017 Jan;45(1):1-10.
- 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.
- 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.
- 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.
Responsible Party:
Inflammatix
ClinicalTrials.gov Identifier:
NCT03606382
Other Study ID Numbers:
- DEV-INF-01
First Posted:
Jul 30, 2018
Last Update Posted:
Sep 23, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: