Comparison Between Nasopharynx and Orobuccal/Nasal Swabs or Saliva for Detection of Respiratory Viruses (ORASAMP)

Insel Gruppe AG, University Hospital Bern1 site in 1 country501 target enrollmentDecember 19, 2024

ConditionsRespiratory Tract Infection Viral

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Respiratory Tract Infection Viral
Sponsor: Insel Gruppe AG, University Hospital Bern
Enrollment: 501
Locations: 1
Primary Endpoint: Sensitivity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab.
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this observational study is to validate the use of less invasive samples (saliva, orobuccal or nasal swabs) than nasopharyngeal swab for testing common and clinically relevant respiratory viruses in children and adults presenting to an emergency departements with symptoms compatible with respiratory tract infection. The main question it aims to answer is:

Is the precision of reverse transcription polymerase chain reaction (RT-PCR) for Influenzavirus A or B, respiratory syncytial virus (RSV), and Rhinovirus, on saliva, orobuccal swabs and nasal swabs comparable to the gold standard nasopharyngeal swab in a pediatric and adult population presenting with symptoms compatible with respiratory tract infection.

Among participants the following samples will be collected (nasopharyngeal swab is standard of care and not part of the study samples):

Saliva
Orobuccal swab
Nasal swab

Registry

clinicaltrials.gov

Start Date

December 19, 2024

End Date

June 20, 2025

Last Updated

10 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Insel Gruppe AG, University Hospital Bern

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients presenting at the emergency departments or hospitalized at Inselspital Bern university hospital with any symptom compatible with an acute respiratory tract infection in whom a nasopharyngeal swab to test for respiratory viruses is performed (standard of care)
•Written informed consent from the trial subject has been obtained; for patients aged 0-13 years, or not able to provide informed consent, consent obtained from the legal representative; for patients between 14-18 years, written informed consent obtained from the respective patient as well as the legal representative.

Exclusion Criteria

•Patients unable to provide a saliva (e.g. patients with reduced level of consciousness). Children too young to be instructed to provide saliva are not excluded, but saliva won't be collected.
•Patients with swallowing disturbances
•Patient's lack of accountability and inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly AND legal representative not available.

Outcomes

Primary Outcomes

Sensitivity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab.

Time Frame: At baseline

Specificity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab.

Time Frame: At baseline

Secondary Outcomes

Area under the receiver operating characteristic (ROC) curve for the detection of Influenza A/B, RSV and Rhinovirus in each study sample (orobuccal or nasal swab and saliva).(At baseline)
Positive agreement between viral copy number of RT-PCR for Influenzavirus A or B, RSV, and Rhinovirus, Parainfluenzavirus, Adenovirus, human Metapneumovirus in saliva, orobuccal swabs and nasal swabs compared to nasopharyngeal swabs.(At baseline)
Negative agreement between viral copy number of RT-PCR for Influenzavirus A or B, RSV, and Rhinovirus, Parainfluenzavirus, Adenovirus, human Metapneumovirus in saliva, orobuccal swabs and nasal swabs compared to nasopharyngeal swabs.(At baseline)
Prevalence of respiratory viruses in orobuccal, nasal or nasopharyngeal swabs and saliva.(At baseline)
Sensitivity of RT-PCR for Parainfluenzavirus, Adenovirus and human Metapneumovirus in orobuccal, nasal and saliva samples.(At baseline)
Specificity of RT-PCR for Parainfluenzavirus, Adenovirus and human Metapneumovirus in orobuccal, nasal and saliva samples.(At baseline)
Incremental yield of virus detection in orobuccal, nasal and saliva as compared to nasopharyngeal samples.(At baseline)
Co-prevalence of respiratory viruses in orobuccal, nasal or nasopharyngeal swabs and saliva.(At baseline)
Association between predefined symptoms and probability for positive RT-PCR of specific viruses using different (nasopharyngeal, orobuccal, nasal, saliva) samples.(At baseline)
Comparative cycling time values at the different sampling locations(At baseline)