Detecting Respiratory Viruses in Upper and Lower Respiratory Tract Samples

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) Identifier:
First received: May 10, 2012
Last updated: March 5, 2015
Last verified: February 2015


- 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.


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


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


  • 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

Respiratory Viruses

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Detection of Respiratory Viruses in Upper and Lower Respiratory Tract Specimens Using a Rapid Multiplex PCR

Further study details as provided by National Institutes of Health Clinical Center (CC):

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. [ Time Frame: Within 30 days after collection ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2012
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.

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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.


  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01597089

Contact: Debra Reda, R.N. (301) 496-9320
Contact: Daniel S Chertow, M.D. (301) 496-9320

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Principal Investigator: Daniel S Chertow, M.D. National Institutes of Health Clinical Center (CC)
  More Information