Assessment of Assay for Rapid Identification of Bloodstre... | NCT04147975

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

NCT04147975

Sponsor

HelixBind, Inc.

Status

Unknown status

Last Update Posted

Nov 1, 2019Actual

Enrollment

225Estimated

Phase

Not provided

Conditions

Bacteremia
Candidemia

Interventions

RaPID/BSI Test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Oct 30, 2020Estimated

First Submitted Date

Oct 29, 2019

First Submission Date that Met QC Criteria

Oct 31, 2019

First Posted Date

Nov 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2019

Last Update Posted Date

Nov 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

225Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients Suspected of Bloodstream Infection		No intervention(s) to be administered.	Diagnostic Test: RaPID/BSI Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RaPID/BSI Test	Diagnostic Test	RaPID/BSI Test	Patients Suspected of Bloodstream Infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Determined to have a positive blood culture.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults who are culture positive for bacterial or fungal bloodstream infection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Reeve	Contact	508-460-1028		mreeve@helixbind.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HelixBind Inc.	Recruiting	Marlborough	Massachusetts	01752	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016470	Bacteremia
D058387	Candidemia

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D018805	Sepsis

Browse Leaves

Not provided

Browse Branches

Not provided