Detecting Respiratory Viruses in Upper and Lower Respiratory Tract Samples

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Terminated

CT.gov ID

NCT01597089

Collaborator

(none)

Enrollment

Location

67.9

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Viruses

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.

Study Design

Study Type:

Observational

Actual Enrollment :

35 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2012

Study Completion Date :

May 1, 2018

Outcome Measures

Primary Outcome Measures

The presence or absence of one or more of the 15 respiratory viruses in upper or lower respiratory tract samples using the FilmArray assay. [Within 30 days after collection]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:
Age 12 years or above
Scheduled for clinically indicated bronchoscopy for the collection of a BAL specimen and will have respiratory virus PCR ordered on the BAL specimen as part of their ongoing care at the NIH Clinical Center.
Must agree to allow the storage of their samples (BAL and NP) for use in future research.