FLUA+B: FLU A+B Nasal Swab Clinical Study

• Sponsor: Response Biomedical Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00636662
• Collaborator: (none)
• Enrollment: 800
• Locations: 5
• Duration (Months): 3
• Patients Per Site: 160
• Patients Per Site Per Month: 54.1

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to obtain clearance for the nasal swab sample type by demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory culture for Influenza A and B viruses using nasal swab samples.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Other: Non-invasive diagnostic testing

Detailed Description

Patients exhibiting symptoms of influenza enrolled in a fashion that confidentiality of all personal health information is maintained.

No patient treatment is affected by enrollment in this trial.

Study Design

• Study Type: Observational
• Actual Enrollment: 800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of the RAMP FLU A+B Test Versus Viral Culture Using Clinical Nasal Swab Samples From Patients With Suspected Influenza Infections
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
all any patient exhibiting symptoms of influenza	Other: Non-invasive diagnostic testing; No patient treatment is altered by enrollment in this trial

Outcome Measures

Primary Outcome Measures

1. Support the addition of nasal swab sample type to labeling for the FLU A+B Test. The nasal swab sample data will be analyzed for the FLU A+B Test versus standard laboratory culture identification to determine the sensitivity and specificity. [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and Female of all age groups

• Patients exhibiting influenza symptoms (i.e., fever, body aches, headaches, cough, sore throat, and other respiratory symptoms) at the time of examination

• Patients must either present with a fever (>100ºF; >37.8ºC) at time of examination or have had a fever (>100ºF; >37.8ºC) or declare at time of the examination that they had a fever within the previous 3 days prior to the examination

• Must be able to collect sample using the nasal swab sample type

Exclusion Criteria:

• Patients with no fever at time of examination or within the 3 days prior to examination and/or are currently undergoing treatment (including anti-virals) will be excluded from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States
2	Washington University / St. Louis Children's Hospital	Saint Louis	Missouri	United States
3	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States
4	Dell Children's Hospital	Austin	Texas	United States
5	Mt. Sinai Hospital	Toronto	Ontario	Canada

Sponsors and Collaborators

• Response Biomedical Corp.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Response Biomedical Corp.
• ClinicalTrials.gov Identifier: NCT00636662
• Other Study ID Numbers: CSP012
• First Posted: Mar 14, 2008
• Last Update Posted: Mar 27, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Mar 27, 2019