Sample Collection to Evaluate an Investigational Instrument for the Detection of Respiratory Viruses in Nasopharyngeal Swabs

Viral Respiratory Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806285
• Other study ID #: CTP0001
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: December 23, 2015
• Start date: February 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: GenMark Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to establish the clinical performance characteristics of the investigational instrument.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: November 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The specimen is a nasopharyngeal swab.

• The specimen is from a pediatric or adult male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long term care facility.

• The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis, and pneumonia.

Exclusion Criteria:

• The specimen is not a nasopharyngeal swab.

• The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Viral Respiratory Infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GenMark Diagnostics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sample collection study only		prospective sample collection	No