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

NCT ID: NCT00613184

Last Updated: 2008-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-01-31

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.

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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.

Conditions

Respiratory Syncytial Virus; Human Metapneumovirus; Influenza; Bronchiolitis; Pediatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Nylon Flocked swab Left Nasal Wash right

Group Type: EXPERIMENTAL

Nylon Flocked swab (Nasal secretion sampling)

Intervention Type: DEVICE

Nasal Aspirate Nylon Flocked swab

Nylon Flocked swab (Nasal secretion sampling)

Intervention Type: DEVICE

Nylon flocked swab Nasal Wash

2

Nylon Flocked swab R Nasal Wash L

Group Type: EXPERIMENTAL

Nylon Flocked swab (Nasal secretion sampling)

Intervention Type: DEVICE

Nasal Aspirate Nylon Flocked swab

3

Nasal Wash Left Nylon Flocked swab Right

Group Type: EXPERIMENTAL

Nylon Flocked swab (Nasal secretion sampling)

Intervention Type: DEVICE

Nasal Aspirate Nylon Flocked swab

4

Nasal Wash R Nylon flocked swab L

Group Type: EXPERIMENTAL

Nylon Flocked swab (Nasal secretion sampling)

Intervention Type: DEVICE

Nasal Aspirate Nylon Flocked swab

Interventions

Nylon Flocked swab (Nasal secretion sampling)

Nasal Aspirate Nylon Flocked swab

Intervention Type: DEVICE

Nylon Flocked swab (Nasal secretion sampling)

Nylon flocked swab Nasal Wash

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Treating clinican ordered RSV antigen testing

Exclusion Criteria

• Refusal of consent
• Age > 18 months

• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Diagnostic Laboratories, LLC

INDUSTRY

Sponsor Role: collaborator

Copan Innovation Murrietta, CA

UNKNOWN

Sponsor Role: collaborator

Kern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Department of Emergency Medicine, Kern Medical Center

Principal Investigators

Paul Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

Kern Medical Center & David Geffen School of Medicine UCLA

Other Identifiers

kmc06037

Identifier Type: -

Identifier Source: org_study_id