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

• Conditions: Candidemia; Bacteremia
• Interventions: Diagnostic Test: RaPID/BSI Test

• Registration Number: NCT04147975
• Lead Sponsor: HelixBind, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-01
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-31
• Last Update Submitted: 2019-10-31
• Study First Posted: 2019-11-01
• Last Update Posted: 2019-11-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Determined to have a positive blood culture.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Suspected of Bloodstream Infection	RaPID/BSI Test	No intervention(s) to be administered.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

HelixBind Inc.; 🇺🇸 Marlborough, Massachusetts, United States