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NCT04147975 Clinical Trial

Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood

Bacteremia Clinical Trial

Official title:
Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04147975
Other study ID # 20031
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date October 30, 2020

Study information
Verified date October 2019
Source HelixBind, Inc.
Contact Michael Reeve
Phone 508-460-1028
Email mreeve@helixbind.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of RaPID/BSI by testing its performance compared to blood cultures collected prospectively from consented subjects.

Recruitment information / eligibility
Status Recruiting
Enrollment 225
Est. completion date October 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Determined to have a positive blood culture.

Exclusion Criteria:

-

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• RaPID/BSI Test
RaPID/BSI Test

Locations
Country Name City State
United States HelixBind Inc. Marlborough Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
HelixBind, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and Specificity compared to Blood Culture (comparator method) The primary endpoint of sensitivity (detection of on panel pathogen) and specificity will be determined by comparing blood culture results with the RaPID/BSI results from the prospective clinical specimens. Up to 24 hours following blood collection
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