Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-31 @ 6:44 AM
Study NCT ID:
NCT04282135
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-12', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cluster Analysis of MCC IMS spectra.', 'timeFrame': 'immediatly after sampling', 'description': 'Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '33578396', 'type': 'DERIVED', 'citation': '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': '33089824', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.', 'detailedDescription': 'Bacterial infections can be distinguished by analysis of the volatile organic compounds found in breath.\n\nIn 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.\n\nMCC IMS spectra will be compared between infected and non infected patients by cluster analysis and discrimination analysis.\n\nIf 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.\n\nDue to decreasing numbers of Influenza-A- Infections study was opened to also include patients with suspected SARS-CoV-2 infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'general population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected Influenza infection\n\nExclusion Criteria:\n\n* later than 48h after admission and detection of Influenza infection\n* later than 32 days after admission and detection of SARS-CoV-2- infection\n* no written consent'}, 'identificationModule': {'nctId': 'NCT04282135', 'briefTitle': 'Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling', 'organization': {'class': 'INDUSTRY', 'fullName': 'Klinikum Bayreuth GmbH'}, 'officialTitle': 'Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling', 'orgStudyIdInfo': {'id': 'IMS 1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infected', 'description': 'patients with detected Influenza RNA in nasopharyngeal swabs', 'interventionNames': ['Diagnostic Test: MCC IMS']}, {'label': 'not infected', 'description': 'patients without detected Influenza RNA in nasopharyngeal swabs', 'interventionNames': ['Diagnostic Test: MCC IMS']}, {'label': 'SARS CoV2', 'description': 'patients with SARS-Cov-2 infection', 'interventionNames': ['Diagnostic Test: MCC IMS']}], 'interventions': [{'name': 'MCC IMS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnosis by MCC IMS', 'armGroupLabels': ['Infected', 'SARS CoV2', 'not infected']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95445', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Klinikum Bayreuth', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}], 'overallOfficials': [{'name': 'Claus Steppert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Bayreuth, Dpt. Pulmonology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum Bayreuth GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Department of pulmonology and thoracic oncology', 'investigatorFullName': 'Claus Steppert', 'investigatorAffiliation': 'Klinikum Bayreuth GmbH'}}}}