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

Completed

• Conditions: Influenza
• Interventions: Diagnostic Test: MCC IMS

• Registration Number: NCT04282135
• Lead Sponsor: Klinikum Bayreuth GmbH

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.

Study Timeline

• Study Start: 2020-02-15
• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-24
• Primary Completion: 2020-05-08
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-12
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS CoV2	MCC IMS	patients with SARS-Cov-2 infection
not infected	MCC IMS	patients without detected Influenza RNA in nasopharyngeal swabs
Infected	MCC IMS	patients with detected Influenza RNA in nasopharyngeal swabs

Primary Outcome Measures

Name	Time	Method
Cluster Analysis of MCC IMS spectra.	immediatly after sampling	Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling

Trial Locations

Locations (1)

Klinikum Bayreuth; 🇩🇪 Bayreuth, Germany