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

• Sponsor: Klinikum Bayreuth GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04282135
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 17

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Feb 15, 2020
• Actual Primary Completion Date: May 8, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Cluster Analysis of MCC IMS spectra. [immediatly after sampling]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Bayreuth	Bayreuth		Germany	95445

Sponsors and Collaborators

• Klinikum Bayreuth GmbH

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Feb 24, 2020
• Last Update Posted: Jul 14, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Influenza, Human; COVID-19

Study Results

No Results Posted as of Jul 14, 2020