Recruiting

Observational StudyAssessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood

Sponsor:

HelixBind, Inc.

Code:

NCT04147975

Conditions

Bacteremia

Candidemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RaPID/BSI Test

Study Details

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.

Conditions

Bacteremia

Candidemia

Study ID

NCT04147975

Start date

Oct 1, 2019

Status verified date

Oct, 2019

Completion date

Oct 30, 2020

Anticipated

Primary completion date

Sep 30, 2020

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Determined to have a positive blood culture.

Exclusion Criteria:

-

Study Design

Enrollment

225 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients Suspected of Bloodstream Infection

No intervention(s) to be administered.

Interventions

RaPID/BSI Test

Primary outcome measure

Sensitivity and Specificity compared to Blood Culture (comparator method) [ Time Frame: Up to 24 hours following blood collection ]

Central Contacts and Locations

Central contacts

Michael Reeve

508-460-1028 mreeve@helixbind.com

Locations

HelixBind Inc.

Recruiting

Marlborough, Massachusetts, United States, 01752

More Information

Sponsor

HelixBind, Inc.

Last update posted

Nov 1, 2019

Last verified

Oct, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HelixBind, Inc. on 2019-11-01.