Smelling infections - Detection of Respiratory Syncitial Virus and other respiratory pathogens using non-invasive diagnostic methods
Organizational Data
- DRKS-ID:
- DRKS00028935
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-05-30
- Last update in DRKS:
- 2023-07-21
- Registration type:
- Retrospective
Acronym/abbreviation of the study
RSVoC
URL of the study
No Entry
Brief summary in lay language
During SARS-CoV-2 pandemic, social life was largely shut down. Several lockdown periods took place, during, and children lived with increased hygiene measures and had only few contacts. The predominant virus causing respiratory infections was SARS-CoV-2, but starting in September 2021, there was an increased emergence of another virus causing respiratory infections in children: the respiratory syncytial virus (RSV). RSV is one of the most common pathogens of lower respiratory tract infections in children and can lead to bronchiolitis and pneumonia, especially in high-risk groups, where hospitalization is often indicated due to respiratory failure and the need of oxygen therapy. Currently, diagnosis of RSV infection requires a throat swab, which is very uncomfortable, especially for young children, and causes additional stress to already sensitive children due to coughing or gagging. We would now like to establish new diagnostic methods based on the detection of certain odorous substances, the so-called volatile organic compounds (VOCs). They are produced during various processes in the body and are released via sweat, exhaled air and stool/urine. In the future, it should be possible to make a rapid and non-invasive diagnosis of RSV and other respiratory tract infections using the "electronic nose" method or ion mobility spectrometry (IMS): the methods can detect odor patterns and changes in the odor pattern that are typical of diseases. They could be used in the future as a screening device for RSV infections and other respiratory infections. For the corresponding analyses, children exhale into a bag, and we also collect saliva samples/sputum as well as stool and urine. We collect sweat from under the armpits, neck and forehead with a swab. The analyses are performed in the research laboratory for general Pediatrics and Neonatology at Saarland University.
Brief summary in scientific language
During the SARS-CoV-2 pandemic, social life was largely shut down. There were several lockdown periods when the population, including children, lived under increased hygiene measures and had only few social contacts. Now, since September 2021, after a period when almost only SARS-CoV-2 was detectable as a respiratory virus, an increased incidence of respiratory syncytial virus (RSV) infections in children has become noticeable. RSV is one of the most common pathogen of lower respiratory tract infections in children and can lead to bronchiolitis and pneumonia. Especially in high-risk groups children need to hospitalized because of an increased risk of apnea and the need of oxygen therapy. To diagnose RSV infections, a nasopharyngeal swab is currently necessary, which is very uncomfortable, especially for young children, and is a stressor for the already sensitive children due to coughing or gagging. In order to optimize this problem in the future, we would like to establish innovative diagnostic procedures based on the detection of certain odorous substances, the so-called volatile organic compounds (VOCs). They are produces during various processes in the body and are released via sweat, exhaled air and excrements. By means of electronic nose or Ion Mobility Spectrometry (IMS), a rapid and non-invasive RSV diagnosis should be possible in the future: the electronic nose can detect odor patterns. With the IMS, it is even possible to determine individual substances and to identify biomarkers for diseases. We want to investigate if there are disease-specific changes in the odor pattern („VOC profile“) and if they can be used as a screening device for RSV infections and other respiratory infections in the future. For the corresponding analyses, children exhale into a bag, and we also collect saliva samples/sputum as well as stool and urine. We collect sweat from under the armpits, neck and forehead with a swab. The analyses are performed in the research laboratory for general Pediatrics and Neonatology at Saarland University.
Health condition or problem studied
- Free text:
- Infection with RSV
- Free text:
- RSV-bronchiolitis
- Free text:
- RSV pneumonia
- ICD10:
- J21.0 - Acute bronchiolitis due to respiratory syncytial virus
- ICD10:
- J12.1 - Respiratory syncytial virus pneumonia
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 50 children with either a positive rapid RSV test or positive multiplex PCR for RSV: Analysis of exhaled air, saliva, sputum, feces and urine via MCC/IMS and electronic nose device
- Arm 2:
- 50 children with other respiratory infections: Analysis of exhaled air, saliva, sputum, feces and urine via MCC/IMS and electronic nose device
- Arm 3:
- 50 "healthy" children without respiratory infections: Analysis of exhaled air, saliva, sputum, feces and urine via MCC/IMS and electronic nose device
Endpoints
- Primary outcome:
- Creation of disease-specific VOC profiles
- Secondary outcome:
- Differentiation between infected and uninfected individuals regarding VOC profiles
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik für Allg. Pädiatrie und Neonatologie Saarbrücken
Recruitment period and number of participants
- Planned study start date:
- 2022-05-22
- Actual study start date:
- 2022-05-22
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 150
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 5 Years
- Maximum Age:
- 18 Years
- Additional Inclusion Criteria:
- - Children >5 years with acute respiratory disease - Children > 5 years without acute respiratory disease
Exclusion Criteria
results from the inclusion criteria
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum des Saarlandes, Klinik für Allgemeine Pädiatrie und NeonatologieProf. Dr. Michael ZemlinKirrberger Straße66421 HomburgGermany
- Telephone:
- +4968411628412
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum des Saarlandes, Klinik für Allgemeine Pädiatrie und NeonatologieMichelle BousKirrberger Straße66421 HomburgGermany
- Telephone:
- +4968411628412
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum des Saarlandes, Klinik für Allgemeine Pädiatrie und NeonatologieMichelle BousKirrberger Straße66421 HomburgGermany
- Telephone:
- +4968411628412
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum des Saarlandes, Klinik für Allgemeine Pädiatrie und NeonatologieMichelle BousKirrberger Straße66421 HomburgGermany
- Telephone:
- +4968411628412
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Gesellschaft für Neonatologie und pädiatrische Intensivmedizin (GNPI)Chausseestr. 128/12910115 BerlinGermany
- Telephone:
- 030 24 63 20 07
- Fax:
- 030 28 04 68 06
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://gnpi.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission bei der Ärztekammer des SaarlandesFaktoreistr. 466111 SaarbrückenGermany
- Telephone:
- +49-681-4003216
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.aerztekammer-saarland.de/aerzte/ethikkommission/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-03-07
- Ethics committee number:
- 83/22
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-04-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry