Detection of Influenza A, Influenza B, and RSV Using the... | NCT02067286

Studies
Detection of Influenza A, Influenza B, and RSV Using the Liat™ Assays on the Liat™ Analyzer

NCT02067286

Sponsor

IQuum, Inc.

Status

Completed

Last Update Posted

Aug 31, 2016Estimated

Enrollment

1,642Actual

Phase

Not provided

Conditions

Influenza A
Influenza B
Respiratory Syncytial Virus (RSV)

Interventions

Not provided

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Feb 14, 2014

First Submission Date that Met QC Criteria

Feb 19, 2014

First Posted Date

Feb 20, 2014Estimated

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

Aug 30, 2016

Last Update Posted Date

Aug 31, 2016Estimated

Name	Class
Roche Molecular Systems, Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to evaluate the clinical sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.

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

1,642Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to an FDA-cleared nucleic acid amplification test		1 day

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to culture		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients exhibiting 2 or more symptom groups characteristic of influenza and/or RSV at the time of visit or within the past 48 hours:
1. fever of at least 37.8 C (100F)
2. runny or stuffy nose
3. coughing, wheezing or difficulty breathing
4. sore throat, headache, extreme tiredness, or muscle aches
5. infants: decreased activity, irritability, poor feeding
Subject who are able to understand and consent to participation; for minors under the age of 18, this includes a parent or legal guardian

Exclusion Criteria:

Patients who are under-going anti-viral medication now or within the last 7 days.
Patients who received Nasal Spray Flu Vaccine within the last 6 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects must be exhibiting symptoms characteristic of influenza or RSV

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatrics-by-the-Sea		Delray Beach	Florida	33483	United States
Meridian Clinical Research

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