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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

Tracking Information
First Submitted Date August 26, 2021
First Posted Date September 14, 2021
Last Update Posted Date September 14, 2021
Actual Study Start Date August 26, 2021
Estimated Primary Completion Date October 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2021)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 7, 2021)
  • 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
  • Comfort Assessment [ Time Frame: 3 months ]
    The comfort and preference of the Rhinoswab compared to the CTDN swab on a Likert Scale
  • Laboratory Assessment [ Time Frame: 3 months ]
    Laboratory handling assessment of Rhinoswab compared to the CTDN swab on a Likert Scale
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
Official Title Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
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.
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.

Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
Sampling Method Probability Sample
Study Population Children aged between 4 - 18 years of age who present for respiratory virus testing
Condition SARS CoV 2 Infection
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 7, 2021)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 26, 2022
Estimated Primary Completion Date October 26, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Shidan Tosif, MBBS FRACP PhD 0413484876 shidan.tosif@rch.org.au
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT05043623
Other Study ID Numbers HREC/77305/RCHM-2021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
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
Responsible Party Shidan Tosif, Murdoch Childrens Research Institute
Study Sponsor Murdoch Childrens Research Institute
Collaborators Rhinomed Pty Ltd
Investigators Not Provided
PRS Account Murdoch Childrens Research Institute
Verification Date September 2021