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Clinical Trials/NCT01597089
NCT01597089
Terminated
Not Applicable

Detection of Respiratory Viruses in Upper and Lower Respiratory Tract Specimens Using a Rapid Multiplex PCR

National Institutes of Health Clinical Center (CC)1 site in 1 country35 target enrollmentSeptember 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Viruses
Sponsor
National Institutes of Health Clinical Center (CC)
Enrollment
35
Locations
1
Primary Endpoint
The presence or absence of one or more of the 15 respiratory viruses in upper or lower respiratory tract samples using the FilmArray assay.
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

Background:

  • Bronchoalveolar lavage (BAL) is a procedure where a tube is passed through the mouth or nose into the lungs. Fluid is squirted through the tube into a part of the lung and then collected for examination. It is used to detect respiratory viruses. BAL is a relatively invasive procedure, and researchers want to test the accuracy of other procedures that do not involve collecting fluid from the lungs. The nasopharynx is the area of the upper throat that lies behind the nose. Researchers want to see if a swab taken from this area is as accurate as a BAL sample.

Objectives:

  • To see if a nasopharynx swab can be used to detect respiratory viruses as well as BAL samples.

Eligibility:

  • Individuals at least 12 years of age who will have a bronchoscopy to collect a BAL sample to test for respiratory viruses.

Design:

  • Participants will be screened with a physical exam and medical history.
  • Participants will have a BAL sample collected.
  • Participants will then have a nasopharynx swab. The swab will be inserted into the nose, left in place for up to 10 seconds, and then removed

Detailed Description

Bronchoalveolar lavage (BAL) specimens can be used for the detection of respiratory viruses. Although bronchoscopy is relatively safe, it still has inherent risks to the subject. Nasopharyngeal (NP) swab specimens are easy to collect and are minimally invasive for the subject. We will use a rapid multiplex polymerase chain reaction (PCR) to detect respiratory viruses in paired BAL and NP specimens to determine if either specimen is more likely to be positive. The study population will include all patients undergoing bronchoscopy for clinical indications at the Clinical Center. This is a prospective observational study.

Registry
clinicaltrials.gov
Start Date
September 1, 2012
End Date
May 1, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The presence or absence of one or more of the 15 respiratory viruses in upper or lower respiratory tract samples using the FilmArray assay.

Time Frame: Within 30 days after collection

Study Sites (1)

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