- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04282135
Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bayreuth, Germany, 95445
- Klinikum Bayreuth
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study 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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Infected
patients with detected Influenza RNA in nasopharyngeal swabs
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Diagnosis by MCC IMS
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not infected
patients without detected Influenza RNA in nasopharyngeal swabs
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Diagnosis by MCC IMS
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SARS CoV2
patients with SARS-Cov-2 infection
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Diagnosis by MCC IMS
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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
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immediatly after sampling
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claus Steppert, MD, Klinikum Bayreuth, Dpt. Pulmonology
Publications and helpful links
General Publications
- Steppert C, Steppert I, Sterlacci W, Bollinger T. Rapid detection of SARS-CoV-2 infection by multicapillary column coupled ion mobility spectrometry (MCC-IMS) of breath. A proof of concept study. J Breath Res. 2021 Mar 18;15(2). doi: 10.1088/1752-7163/abe5ca.
- Steppert C, Steppert I, Bollinger T, Sterlacci W. Rapid non-invasive detection of Influenza-A-infection by multicapillary column coupled ion mobility spectrometry. J Breath Res. 2020 Oct 22;15(1):011001. doi: 10.1088/1752-7163/abb762.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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