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NCT00613184 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00613184
Other study ID # kmc06037
Secondary ID
Status Unknown status
Phase N/A
First received January 29, 2008
Last updated February 11, 2008
Start date November 2006
Est. completion date January 2008

Study information
Verified date January 2008
Source Kern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 150
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Months
Eligibility Inclusion Criteria:

- Treating clinican ordered RSV antigen testing

Exclusion Criteria:

- Refusal of consent

- Age > 18 months

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Nylon Flocked swab (Nasal secretion sampling)
Nasal Aspirate Nylon Flocked swab
• Nylon Flocked swab (Nasal secretion sampling)
Nylon flocked swab Nasal Wash

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Kern Medical Center Copan Innovation Murrietta, CA, Medical Diagnostic Laboratories, LLC

Outcome
Type Measure Description Time frame Safety issue
Primary Viral detection rate by PCR 0 not applicable
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