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Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior

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ClinicalTrials.gov Identifier: NCT05043623
Recruitment Status : Recruiting
First Posted : September 14, 2021
Last Update Posted : September 14, 2021
Sponsor:
Collaborator:
Rhinomed Pty Ltd
Information provided by (Responsible Party):
Shidan Tosif, Murdoch Childrens Research Institute

Brief Summary:
A study to investigate Rhinoswab as an alternative method to combined throat and deep nasal (CTDN) swab for respiratory sample collection in children who present to the Royal Children's Hospital (RCH) for viral testing. Children and their parent/guardian will answer a short survey about their preferences. Laboratory staff will answer a short survey about handling the different samples.

Condition or disease Intervention/treatment
SARS CoV 2 Infection Device: Rhinoswab Junior

Detailed Description:

The microbiological test of choice for detection of respiratory viruses is a reverse transcription polymerase chain reaction (RT-PCR). The test is reported as "detected" or "not-detected" to the clinician. The Ct-value is a microbiological analysis that represents the number of amplification cycles required for a target gene to exceed a threshold level, to determine a negative or positive result and is interpreted to detect respiratory viruses. The Ct-value is used to measure viral load.

SARS-CoV-2, the virus that causes COVID-19, is a respiratory virus of specific interest. SARS-CoV-2 is detected in the upper respiratory tract. National guidelines for diagnosing COVID-19 in Australia require a combined throat and deep nasal swab (CTDN). No other testing options are routinely recommended in Australia. However, research and international guidelines recommend nasal swabs alone for SARS-CoV-2 detection. The Center for Disease Control and Prevention (USA) currently recommend the use of an anterior nasal swab alone as a method for detection of SARS-CoV-2. A recent systematic review suggested nasal swabs are a clinically acceptable alternative specimen collection methods. In addition to satisfactory diagnostic performance, nasal swabs are potentially less invasive, and can be self-collected.

Research at the Melbourne Children's Campus has identified that the CTDN or nasopharyngeal swab, are uncomfortable and distressing for children. The fear of the test is a barrier for presentation to a health service for a SARS-CoV-2 test. Parental and child reluctance to undergo testing may impact the public health response, through under-identification of pediatric cases.

The Rhinoswab is a TGA approved anterior nasal swab for children and adults. The design of the Rhinoswab allows for standardisation of the site of biological sampling, as compared with CTDN swabs which are operator dependent. It is designed to be more comfortable and to collect nasal secretions for PCR testing. The Rhinoswab Junior is a smaller paediatric version that has novelty features which add interest and distraction. The child can use the swab themselves, allowing autonomy and control. The capture and elution efficiency of the Rhinoswab has been shown to be comparable, if not slightly superior, to the capture and elution efficiency to the commercially available Copan eSwab by VIDRL and GNOMIX analyses.

The RCH has completed over 30,000 tests in children throughout the COVID-19 Pandemic from March 2020 to June 2021 at the Respiratory Infection Clinic and Emergency Department. The RCH nurses and doctors are well placed to trial the Rhinoswab due to extensive experience in testing children, and have developed related clinical practice guidelines.

This trial aims to determine if the Rhinoswab is as sensitive and specific as the standard CTDN swab, in detecting respiratory viruses, in children aged 4-18 years. This study also aims to understand which swab children prefer, and how the swabs compare when being handled in the laboratory.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
Actual Study Start Date : August 26, 2021
Estimated Primary Completion Date : October 26, 2021
Estimated Study Completion Date : January 26, 2022

Intervention Details:
  • Device: Rhinoswab Junior
    To determine the sensitivity and specificity of the Rhinoswab compared to the standard CTDN swab, in detecting viruses on the respiratory panel


Primary Outcome Measures :
  1. PCR ct value of viruses detected on respiratory panel of the Rhinoswab junior [ Time Frame: 3 months ]
    Rhinoswab junior sample will be tested with respiratory panel and CT value recorded


Secondary Outcome Measures :
  1. PCR ct value of viruses detected on respiratory panel on standard of care (combined nose and throat) swab [ Time Frame: 3 months ]
    The standard of care test (combined nose/throat) will be tested for respiratory viruses and CT value recorded

  2. Comfort Assessment [ Time Frame: 3 months ]
    The comfort and preference of the Rhinoswab compared to the CTDN swab on a Likert Scale

  3. Laboratory Assessment [ Time Frame: 3 months ]
    Laboratory handling assessment of Rhinoswab compared to the CTDN swab on a Likert Scale


Biospecimen Retention:   Samples Without DNA
Nasal swabs from the Rhinoswab Junior will be tested with a respiratory viral panel. This will be compared with the respiratory viral panel on the combined deep nasal/throat swab.


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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children aged between 4 - 18 years of age who present for respiratory virus testing
Criteria

Inclusion Criteria:

  • Symptomatic and requiring a COVID-19 test at RCH or confirmed/suspected COVID-19 at home.
  • Aged between 4-18 years old.
  • Parent/guardian present.
  • Parents/self are able to provide consent.

Exclusion Criteria:

  • <4 years old, or >18 years old.
  • Previous head or neck surgery resulting in the absence of a nasal cavity (e.g. rhinectomy).
  • Inability (e.g. non-English speaking) or unwillingness to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05043623


Contacts
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Contact: Shidan Tosif, MBBS FRACP PhD 0413484876 shidan.tosif@rch.org.au

Locations
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Australia, Victoria
Shidan Tosif Recruiting
Parkville, Victoria, Australia, 3052
Contact: Shidan Tosif    0413484876    shidan.tosif@rch.org.au   
Sponsors and Collaborators
Murdoch Childrens Research Institute
Rhinomed Pty Ltd
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Responsible Party: Shidan Tosif, Clinician Scientist, Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT05043623    
Other Study ID Numbers: HREC/77305/RCHM-2021
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD is subject to legal commitment preventing release but will be summarised in aggregate form in publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases