Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
NCT ID: NCT04282135
Last Updated: 2020-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
76 participants
OBSERVATIONAL
2020-02-15
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Rapid Flu Testing in BMC ED
NCT02979730
Efficacy and Safety of Molnupiravir in Healthy Participants Inoculated With Experimental Influenza Virus (MK-4482-019)
NCT05818124
Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
NCT01314911
Efficiency of Antagonist Drugs of the Cellular Transcriptomic Signature of Influenza A Virus Infection.
NCT03212716
Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Detecting and Differentiating Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (Flu A), and/or Influenza B (Flu B)
NCT05787444
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Infected
patients with detected Influenza RNA in nasopharyngeal swabs
MCC IMS
Diagnosis by MCC IMS
not infected
patients without detected Influenza RNA in nasopharyngeal swabs
MCC IMS
Diagnosis by MCC IMS
SARS CoV2
patients with SARS-Cov-2 infection
MCC IMS
Diagnosis by MCC IMS
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MCC IMS
Diagnosis by MCC IMS
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* later than 32 days after admission and detection of SARS-CoV-2- infection
* no written consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Klinikum Bayreuth GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Claus Steppert
Director Department of pulmonology and thoracic oncology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claus Steppert, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Bayreuth, Dpt. Pulmonology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Klinikum Bayreuth
Bayreuth, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IMS 1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.