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OpenTrials
Completed

NCT Number: NCT04282135

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

Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.

Completed

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Bayreuth

Bayreuth, 95445, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCC IMS

Diagnostic Test

Diagnosis by MCC IMS

Primary outcomes

  1. Cluster Analysis of MCC IMS spectra.

    Time frame: immediatly after sampling

    Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling

Sponsors and collaborators

Lead sponsor

Klinikum Bayreuth GmbH

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2020
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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