Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-02 @ 8:54 AM
Study NCT ID:
NCT06743750
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2024-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Different Sampling Sites for Detection of Respiratory Viruses
Sponsor:
Insel Gruppe AG, University Hospital Bern
Organization:
Study Overview
Official Title:
Comparison Between Nasopharynx and Orobuccal/Nasal Swabs or Saliva for Detection of Respiratory Viruses (ORASAMP)
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORASAMP
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
\- 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: