FindTrial
Sign In

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04147975
Enrollment
225
Registered
2019-11-01
Start date
2019-10-01
Completion date
2020-10-30
Last updated
2019-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Candidemia

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.

Interventions

DIAGNOSTIC_TESTRaPID/BSI Test

RaPID/BSI Test

Sponsors

HelixBind, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Determined to have a positive blood culture.

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity and Specificity compared to Blood Culture (comparator method)Up to 24 hours following blood collectionThe 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.

Countries

United States

Contacts

Primary ContactMichael Reeve
mreeve@helixbind.com508-460-1028

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026