InfluenzaNCT04282135
Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
An observational study of Influenza, run by Klinikum Bayreuth GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- MCC IMS
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- 15 Feb 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: general population
Who may be able to join
- suspected Influenza infection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.
Read the 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.
- Conditions
- Influenza
- Being tested
- MCC IMS
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCC IMSDiagnostic test
Diagnosis by MCC IMS
| Study group | Role | What they receive |
|---|---|---|
| Infected | patients with detected Influenza RNA in nasopharyngeal swabs Receives: Diagnostic Test: MCC IMS | |
| not infected | patients without detected Influenza RNA in nasopharyngeal swabs Receives: Diagnostic Test: MCC IMS | |
| SARS CoV2 | patients with SARS-Cov-2 infection Receives: Diagnostic Test: MCC IMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cluster Analysis of MCC IMS spectra.
Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling
Measured: immediatly after sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start15 Feb 2020
- Primary completion8 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Bayreuth GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Claus Steppert, Klinikum Bayreuth GmbH
- Investigators
- Claus Steppert, MD, Principal investigator, Klinikum Bayreuth, Dpt. Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282135
- Sponsor's protocol ID
- IMS 1
- Status last verified
- Jul 2020
- First submitted
- 20 Feb 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33578396Steppert 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.
PubMed 33089824
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
- ClinicalTrials.gov ID
- NCT04282135
- Acronym / sponsor ID
- IMS 1
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Klinikum Bayreuth GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infected | – | Diagnostic Test: MCC IMSpatients with detected Influenza RNA in nasopharyngeal swabs |
| not infected | – | Diagnostic Test: MCC IMSpatients without detected Influenza RNA in nasopharyngeal swabs |
| SARS CoV2 | – | Diagnostic Test: MCC IMSpatients with SARS-Cov-2 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- general population
Key inclusion criteria (1 listed)
- suspected Influenza infection
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCC IMSDiagnosis by MCC IMS | Diagnostic test | Infected, SARS CoV2, not infected |
Primary outcome
Cluster Analysis of MCC IMS spectra.
Time frame: immediatly after sampling
Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Derived from this study: PubMed 33578396Steppert 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.
- Derived from this study: PubMed 33089824Steppert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Steppert, MD principal investigator
Klinikum Bayreuth, Dpt. Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Klinikum Bayreuth GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cluster Analysis of MCC IMS spectra. (time frame: immediatly after sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04282135, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.