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 Neonatologie
Prof. Dr. Michael Zemlin
Kirrberger Straße
66421 Homburg
Germany
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 Neonatologie
Michelle Bous
Kirrberger Straße
66421 Homburg
Germany
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 Neonatologie
Michelle Bous
Kirrberger Straße
66421 Homburg
Germany
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 Neonatologie
Michelle Bous
Kirrberger Straße
66421 Homburg
Germany
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. 128/129
10115 Berlin
Germany
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 Saarlandes
Faktoreistr. 4
66111 Saarbrücken
Germany
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
UTN (Universal Trial Number):
No Entry
EUDAMED 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