NCT04282135

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

February 20, 2020

Last Update Submit

July 12, 2020

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • Cluster Analysis of MCC IMS spectra.

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

    immediatly after sampling

Study Arms (3)

Infected

patients with detected Influenza RNA in nasopharyngeal swabs

Diagnostic Test: MCC IMS

not infected

patients without detected Influenza RNA in nasopharyngeal swabs

Diagnostic Test: MCC IMS

SARS CoV2

patients with SARS-Cov-2 infection

Diagnostic Test: MCC IMS

Interventions

MCC IMSDIAGNOSTIC_TEST

Diagnosis by MCC IMS

InfectedSARS CoV2not infected

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

general population

You may qualify if:

  • suspected Influenza infection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Bayreuth

Bayreuth, 95445, Germany

Location

Related Publications (2)

  • 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.

    PMID: 33578396DERIVED

  • 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.

    PMID: 33089824DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Claus Steppert, MD

    Klinikum Bayreuth, Dpt. Pulmonology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Department of pulmonology and thoracic oncology

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 24, 2020

Study Start

February 15, 2020

Primary Completion

May 8, 2020

Study Completion

June 30, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)