Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood
Sponsor
HelixBind, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04147975
Collaborator
(none)
225
1
13
17.3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
225 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood
Actual Study Start Date
:
Oct 1, 2019
Anticipated Primary Completion Date
:
Sep 30, 2020
Anticipated Study Completion Date
:
Oct 30, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients Suspected of Bloodstream Infection No intervention(s) to be administered. |
Diagnostic Test: RaPID/BSI Test
RaPID/BSI Test
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and Specificity compared to Blood Culture (comparator method) [Up to 24 hours following blood collection]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Determined to have a positive blood culture.
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HelixBind Inc. | Marlborough | Massachusetts | United States | 01752 |
Sponsors and Collaborators
- HelixBind, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
HelixBind, Inc.
ClinicalTrials.gov Identifier:
NCT04147975
Other Study ID Numbers:
- 20031
First Posted:
Nov 1, 2019
Last Update Posted:
Nov 1, 2019
Last Verified:
Oct 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:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: