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NCT04282135 Clinical Trial

Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling

Influenza Clinical Trial

Official title:
Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04282135
Other study ID # IMS 1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2020
Est. completion date June 30, 2020

Study information
Verified date July 2020
Source Klinikum Bayreuth GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date June 30, 2020
Est. primary completion date May 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- suspected Influenza infection

Exclusion Criteria:

- later than 48h after admission and detection of Influenza infection

- later than 32 days after admission and detection of SARS-CoV-2- infection

- no written consent

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MCC IMS
Diagnosis by MCC IMS

Locations
Country Name City State
Germany Klinikum Bayreuth Bayreuth

Sponsors (1)
Lead Sponsor Collaborator
Klinikum Bayreuth GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cluster Analysis of MCC IMS spectra. Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling immediatly after sampling
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