Comparison Between Different Sampling Sites for Detection of Respiratory Viruses

NCT ID: NCT06743750

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 501 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-19
• Study Completion Date: 2025-06-20

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

Conditions

Respiratory Tract Infection Viral

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Study sample

There is only one group in this study

RT-PCR in different respiratory tract samples

Intervention Type: DIAGNOSTIC_TEST

RT-PCR on saliva, orrobuccal swab and nasal swab will be performed. Nasopharyngeal swab will be performed independently of the study as standard of care.

Interventions

RT-PCR in different respiratory tract samples

RT-PCR on saliva, orrobuccal swab and nasal swab will be performed. Nasopharyngeal swab will be performed independently of the study as standard of care.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 0 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: collaborator

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philipp Jent, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Bern, University of Bern

Locations

Inselspital, University Hospital of Bern

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

5888

Identifier Type: -

Identifier Source: org_study_id