Clinical trial NCT06743750: Comparison Between Different Sampling Sites for Detection of Respiratory Viruses
Official title: Comparison Between Nasopharynx and Orobuccal/Nasal Swabs or Saliva for Detection of Respiratory Viruses (ORASAMP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Tract Infection Viral
Keywords: Viral respiratory tract infection
Diagnostic test performance
Molecular diagnostic
Influenza
RSV
Rhinovirus
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
name: Roche Diagnostics GmbH
First posted: 2024-12-20
Enrollment: 720
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children or adults presenting at the emergency departments or hospitalized at the University Hospital of Bern 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).

Consecutive participant recruitment will be performed at the children and adult emergency departments during working hours of the study nurse.

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


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.

Primary outcomes:
measure: Sensitivity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab.
timeFrame: At baseline
measure: Specificity of RT-PCR for Influenzavirus A or B, RSV and Rhinovirus, on orobuccal or nasal swab and saliva compared to nasopharyngeal swab.
timeFrame: At baseline
Secondary outcomes:
measure: 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).
timeFrame: At baseline
measure: 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.
timeFrame: At baseline
measure: 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.
timeFrame: At baseline
measure: Prevalence of respiratory viruses in orobuccal, nasal or nasopharyngeal swabs and saliva.
timeFrame: At baseline
measure: Sensitivity of RT-PCR for Parainfluenzavirus, Adenovirus and human Metapneumovirus in orobuccal, nasal and saliva samples.
timeFrame: At baseline
measure: Specificity of RT-PCR for Parainfluenzavirus, Adenovirus and human Metapneumovirus in orobuccal, nasal and saliva samples.
timeFrame: At baseline
measure: Incremental yield of virus detection in orobuccal, nasal and saliva as compared to nasopharyngeal samples.
timeFrame: At baseline
measure: Co-prevalence of respiratory viruses in orobuccal, nasal or nasopharyngeal swabs and saliva.
timeFrame: At baseline
measure: Association between predefined symptoms and probability for positive RT-PCR of specific viruses using different (nasopharyngeal, orobuccal, nasal, saliva) samples.
timeFrame: At baseline
measure: Comparative cycling time values at the different sampling locations
timeFrame: At baseline
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, University Hospital of Bern
Study officials:
affiliation: University Hospital of Bern, University of Bern
name: Philipp Jent, MD
role: PRINCIPAL_INVESTIGATOR
References: