Comparing different sample types for detecting respiratory viruses
Comparison Between Nasopharynx and Orobuccal/Nasal Swabs or Saliva for Detection of Respiratory Viruses (ORASAMP)
Insel Gruppe AG, University Hospital Bern · NCT06743750
This study is testing whether easier ways to collect samples, like saliva and nasal swabs, can accurately detect respiratory viruses in both kids and adults who have symptoms of respiratory infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 720 (estimated) |
| Ages | 0 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT06743750 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the effectiveness of less invasive sampling methods, such as saliva, orobuccal swabs, and nasal swabs, for detecting respiratory viruses in patients presenting with symptoms of respiratory tract infections. The study will compare the precision of reverse transcription polymerase chain reaction (RT-PCR) results from these samples against the traditional nasopharyngeal swab, which is considered the gold standard. Participants will include both children and adults who are undergoing standard care testing for respiratory viruses at an emergency department. The goal is to determine if these alternative sampling methods can provide comparable diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates include patients of all ages presenting with symptoms of acute respiratory tract infections at the emergency department of Inselspital Bern.
Not a fit: Patients unable to provide saliva samples or those with swallowing disturbances may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive and more comfortable testing options for patients with respiratory infections.
How similar studies have performed: Other studies have shown promise in using less invasive sampling methods for respiratory virus detection, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bern
- Inselspital, University Hospital of Bern — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Philipp Jent, MD — University Hospital of Bern, University of Bern
- Study coordinator: Philipp Jent, MD
- Email: philipp.jent@insel.ch
- Phone: + 41316322525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory Tract Infection Viral, Viral respiratory tract infection, Diagnostic test performance, Molecular diagnostic, Influenza, RSV, Rhinovirus