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Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior

NCT05043623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2023-02-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Rhinoswab Junior

Rhinoswab Junior is a single use self-administered nasal swab intended to collect clinical specimens from the patient's nasal passages

DEVICE

Combined nose and throat swab

Combined nose and throat swab (standard of care)

DEVICE

Saliva swab

Saliva swab

DIAGNOSTIC_TEST

Abbott Panbio™ COVID-19 antigen self-test kit

COVID-19 antigen self-test kit for the screening of active COVID-19 infection. It is a single-use, in vitro, visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen. It is intended to be used manually by untrained lay users (self testing) in a private setting.

Sponsors & Collaborators

  • Rhinomed Pty Ltd

    collaborator UNKNOWN

  • Murdoch Childrens Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-26
Primary Completion
2022-01-26
Completion
2022-08-28

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05043623 on ClinicalTrials.gov