Detecting Respiratory Viruses in Upper and Lower Respiratory Tract Samples

NCT01597089 | Terminated

• 2 other identifiers: 12012512-CC-0125
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Viruses

Keywords

Specificity; Bronchoalveolar Lavage; Film Array Assay; Nasopharyngeal Swab; Sensitivity

Outcome Measures

Primary Outcomes (1)

• 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

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Kuypers J, Campbell AP, Cent A, Corey L, Boeckh M. Comparison of conventional and molecular detection of respiratory viruses in hematopoietic cell transplant recipients. Transpl Infect Dis. 2009 Aug;11(4):298-303. doi: 10.1111/j.1399-3062.2009.00400.x. Epub 2009 May 11.

  PMID: 19453994 BACKGROUND

• Blyth CC, Iredell JR, Dwyer DE. Rapid-test sensitivity for novel swine-origin influenza A (H1N1) virus in humans. N Engl J Med. 2009 Dec 17;361(25):2493. doi: 10.1056/NEJMc0909049. Epub 2009 Nov 18. No abstract available.

  PMID: 19923563 BACKGROUND

• Soccal PM, Aubert JD, Bridevaux PO, Garbino J, Thomas Y, Rochat T, Rochat TS, Meylan P, Tapparel C, Kaiser L. Upper and lower respiratory tract viral infections and acute graft rejection in lung transplant recipients. Clin Infect Dis. 2010 Jul 15;51(2):163-70. doi: 10.1086/653529.

  PMID: 20524853 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Daniel S Chertow, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 11, 2012
• Study Start: September 1, 2012
• Study Completion: May 1, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-05-01

Locations

US (1)