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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282135
Recruitment Status : Completed
First Posted : February 24, 2020
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Claus Steppert, 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.

Condition or disease Intervention/treatment
Influenza Diagnostic Test: MCC IMS

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.

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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
Actual Study Start Date : February 15, 2020
Actual Primary Completion Date : May 8, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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




Primary Outcome Measures :
  1. Cluster Analysis of MCC IMS spectra. [ Time Frame: immediatly after sampling ]
    Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
general population
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282135


Locations
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Germany
Klinikum Bayreuth
Bayreuth, Germany, 95445
Sponsors and Collaborators
Klinikum Bayreuth GmbH
Investigators
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Principal Investigator: Claus Steppert, MD Klinikum Bayreuth, Dpt. Pulmonology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Claus Steppert, Director Department of pulmonology and thoracic oncology, Klinikum Bayreuth GmbH
ClinicalTrials.gov Identifier: NCT04282135    
Other Study ID Numbers: IMS 1
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases