Detecting Respiratory Viruses in Upper and Lower Respiratory Tract Samples

May 2, 2018 updated by: National Institutes of Health Clinical Center (CC)

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

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

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 30 days after collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Investigators

  • Principal Investigator: Daniel S Chertow, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Study Completion

May 1, 2018

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (Estimate)

May 11, 2012

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120125
  • 12-CC-0125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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