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NCT02067286 Clinical Trial

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

Influenza A Clinical Trial

Official title:
Multi-Center Study of In Vitro Diagnostic Devices for the Detection of Influenza A, Influenza B, and RSV

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02067286
Other study ID # FR4, Rev. 3.3
Secondary ID
Status Completed
Phase N/A
First received February 14, 2014
Last updated August 30, 2016
Start date January 2014
Est. completion date April 2015

Study information
Verified date August 2016
Source IQuum, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1642
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Meridian Clinical Research Bellevue Nebraska
United States Cleveland Clinic Cleveland Ohio
United States Pediatrics-by-the-Sea Delray Beach Florida
United States Accurate Clinical Research Houston Texas
United States Northpoint Pediatrics Indianapolis Indiana
United States Plano Pediatrics Plano Texas
United States Meridian Clinical Research Savannah Georgia
United States Advanced Pediatrics Vienna Virginia

Sponsors (2)
Lead Sponsor Collaborator
IQuum, Inc. Roche Molecular Systems, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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