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

Tracking Information

First Received Date ^ICMJE

January 29, 2008

Last Updated Date

February 11, 2008

Start Date ^ICMJE

November 2006

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Viral detection rate by PCR [ Time Frame: 0 not applicable ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00613184 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Open Label, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Respiratory Syncytial Virus
Human Metapneumovirus
Influenza
Bronchiolitis
Pediatric

Intervention ^ICMJE

Device: Nylon Flocked swab (Nasal secretion sampling)

Study Arms / Comparison Groups

Experimental: Nylon Flocked swab Left Nasal Wash right
Experimental: Nylon Flocked swab R Nasal Wash L
Experimental: Nasal Wash Left Nylon Flocked swab Right
Experimental: Nasal Wash R Nylon flocked swab L

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Treating clinican ordered RSV antigen testing

Exclusion Criteria:

Refusal of consent
Age > 18 months

Gender

Both

Ages

up to 18 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00613184

Responsible Party

Paul Walsh MB BCh FACEP, Department of Emergency Medicine, Kern Medical Center

Study ID Numbers ^ICMJE

kmc06037

Study Sponsor ^ICMJE

Kern Medical Center

Collaborators ^ICMJE

Medical Diagnostic Laboratories
Copan Innovation Murrietta, CA

Investigators ^ICMJE

Principal Investigator:

Paul Walsh, MD

Kern Medical Center & David Geffen School of Medicine UCLA

Information Provided By

Kern Medical Center

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP