Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-31 @ 6:44 AM
Study NCT ID:
NCT04282135
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
Sponsor:
Klinikum Bayreuth GmbH
Organization:
Study Overview
Official Title:
Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
Status:
COMPLETED
Status Verified Date:
2020-07
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:
None
Brief Summary:
Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.
Detailed Description:
Bacterial infections can be distinguished by analysis of the volatile organic compounds found in breath.
In patients with suspected Influenza infection, nasal air samples will be taken and analyzed by Multicapillary Ion mobility spectrometry (MCC IMS). Routinely all patients undergo polymerase chain reaction (PCR) analysis of nasopharyngeal swabs for Influenza.
MCC IMS spectra will be compared between infected and non infected patients by cluster analysis and discrimination analysis.
If the number of infected patients exceeds 50 an additional validation cohort will be investigated sequentially otherwise validation will be performed during the Influenza epidemic 2021.
Due to decreasing numbers of Influenza-A- Infections study was opened to also include patients with suspected SARS-CoV-2 infections.
In patients with suspected Influenza infection, nasal air samples will be taken and analyzed by Multicapillary Ion mobility spectrometry (MCC IMS). Routinely all patients undergo polymerase chain reaction (PCR) analysis of nasopharyngeal swabs for Influenza.
MCC IMS spectra will be compared between infected and non infected patients by cluster analysis and discrimination analysis.
If the number of infected patients exceeds 50 an additional validation cohort will be investigated sequentially otherwise validation will be performed during the Influenza epidemic 2021.
Due to decreasing numbers of Influenza-A- Infections study was opened to also include patients with suspected SARS-CoV-2 infections.
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?: