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Detecting Respiratory Viruses in Upper and Lower Respiratory Tract Samples

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01597089
First received: May 10, 2012
Last updated: August 31, 2016
Last verified: January 2016
  Purpose

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
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.
  Eligibility

Ages Eligible for Study:   12 Years to 99 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

EXCLUSION CRITERIA:

  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 ClinicalTrials.gov identifier: NCT01597089

Contacts
Contact: Debra Reda, R.N. (301) 496-9320 dreda@nih.gov
Contact: Daniel S Chertow, M.D. (301) 496-9320 chertowd@mail.nih.gov

Locations
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    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Investigators
Principal Investigator: Daniel S Chertow, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01597089     History of Changes
Other Study ID Numbers: 120125  12-CC-0125 
Study First Received: May 10, 2012
Last Updated: August 31, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Specificity
Bronchoalveolar Lavage
Film Array Assay
Nasopharyngeal Swab
Sensitivity

ClinicalTrials.gov processed this record on December 02, 2016