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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04282135
Enrollment
76
Registered
2020-02-24
Start date
2020-02-15
Completion date
2020-06-30
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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.

Interventions

DIAGNOSTIC_TESTMCC IMS

Diagnosis by MCC IMS

Sponsors

Klinikum Bayreuth GmbH
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cluster Analysis of MCC IMS spectra.immediatly after samplingCluster Analysis of MCC IMS spectra will be obtained immediately after sampling

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026