Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses

February 11, 2008 updated by: Kern Medical Center

Collection of nasal secretions from infants and toddlers for viral testing is usually done using the nasal washing technique described by Hall in 1975. This is cumbersome. Previous attempts to use swabs have been unsuccessful because the swabs didn't work well. A newly designed swab may work better and in this study we compare the new swab with the old style nasal washing.

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Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Collection of nasal secretions from infants and toddlers for viral testing is typically performed using the nasal saline aspirate technique described by Hall in 1975.

Nylon flocked swabs (NFS) and universal transport medium for room temperature (UTM-RT) (Copan Medical, Murrieta, CA) storage media have been found to be an effective collection and transport method for bacteria causing sexually transmitted infections.

We adapted these swabs and storage medium to collect respiratory viruses from children less than18 months old and compared detection rates using NFS and traditional nasal aspirates. We will determine the relative roles of the UTM-RT and NFS release and therefore measured viral detection rates of common respiratory pathogens in traditional saline aspirates stored in UTM-RT.

Our primary hypothesis is that nasal secretions collection using NFS stored in UTM-RT will lead to a higher detection rate of the respiratory viruses we arestudying; namely RSV, Influenza and human metapneumovirus from than collection of unpreserved saline nasal aspirates in children less than 18 months of age.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

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

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treating clinican ordered RSV antigen testing

Exclusion Criteria:

  • Refusal of consent
  • Age > 18 months

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Nylon Flocked swab Left Nasal Wash right
Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
Device: Nylon Flocked swab (Nasal secretion sampling)
Nylon flocked swab Nasal Wash
Experimental: 2
Nylon Flocked swab R Nasal Wash L
Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
Device: Nylon Flocked swab (Nasal secretion sampling)
Nylon flocked swab Nasal Wash
Experimental: 3
Nasal Wash Left Nylon Flocked swab Right
Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
Device: Nylon Flocked swab (Nasal secretion sampling)
Nylon flocked swab Nasal Wash
Experimental: 4
Nasal Wash R Nylon flocked swab L
Device: Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
Device: Nylon Flocked swab (Nasal secretion sampling)
Nylon flocked swab Nasal Wash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viral detection rate by PCR
Time Frame: 0 not applicable
0 not applicable

Collaborators and Investigators

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

Sponsor

Kern Medical Center

Collaborators

Medical Diagnostic Laboratories, LLC
Copan Innovation Murrietta, CA

Investigators

  • Principal Investigator: Paul Walsh, MD, Kern Medical Center & David Geffen School of Medicine UCLA

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

November 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Anticipated)

January 1, 2008

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 12, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2008

Last Update Submitted That Met QC Criteria

February 11, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kmc06037

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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