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

July 12, 2020 updated by: Claus Steppert, Klinikum Bayreuth GmbH
Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bayreuth, Germany, 95445
        • Klinikum Bayreuth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

general population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infected
patients with detected Influenza RNA in nasopharyngeal swabs
Diagnostic test: MCC IMS
Diagnosis by MCC IMS
not infected
patients without detected Influenza RNA in nasopharyngeal swabs
Diagnostic test: MCC IMS
Diagnosis by MCC IMS
SARS CoV2
patients with SARS-Cov-2 infection
Diagnostic test: MCC IMS
Diagnosis by MCC IMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cluster Analysis of MCC IMS spectra.
Time Frame: immediatly after sampling
Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling
immediatly after sampling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Bayreuth GmbH

Investigators

  • Principal Investigator: Claus Steppert, MD, Klinikum Bayreuth, Dpt. Pulmonology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2020

Primary Completion (Actual)

May 8, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (Actual)

February 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 12, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMS 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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