Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents
- Conditions
- Respiratory DiseasesType 1 DiabetesNeurological Disorders
- Interventions
- Diagnostic Test: Real-time SESI-MS breath analysisDiagnostic Test: Off-line breath analysisDiagnostic Test: Blood analysisDiagnostic Test: Saliva analysisDiagnostic Test: Urine analysis
- Registration Number
- NCT04461821
- Lead Sponsor
- University Children's Hospital Basel
- Brief Summary
This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.
- Detailed Description
Therapeutic drug monitoring (TDM) is defined as measuring concentrations of a drug at one or more time points in a biological matrix after a dose. The purpose of TDM is to individualize the drug dose to achieve maximum efficacy and at the same time minimize toxicity. The concept of TDM could potentially be even more valuable if in addition to drug concentrations, other drug-regulated and drug-related metabolites could be included in the models to define optimal dosage. There exists a clinical need to stratify patients with better precision to improve current clinical and therapeutic management. Breath analysis offers an opportunity to non-invasively retrieve relevant information on the ongoing internal biochemical processes, as well as to monitor the respiratory system itself. For breath analysis, a Secondary Electrospray ionization - mass spectrometry (SESI-MS) breath analysis platform will be used to capture disease-related, drug-regulated and drug-related metabolites (breath metabolomics) in exhaled breath. This information, retrieved in parallel to standard of care clinical co-variates, could have the potential to provide a more personalized therapeutic management of patients.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3600
- Age 0 ≤ 22 years at study entry and signed informed consent
Additional inclusion criteria for respiratory disease population:
- Acute disease: - Acute signs for a respiratory disease, indicated by e.g. increased work of breathing (e.g. dyspnea, increased respiratory rate), cough or wheezing.
- Chronic disease: - Suspected or confirmed chronic airway disease (e.g. asthma).
Additional inclusion criteria for neurological disease population:
- Acute disease: - Acute presentation or report within 24 hours of any signs of neurological deficit (motor function, sensoneural, or verbal).
- Chronic disease: - Confirmed chronic neurologic disease (e.g. childhood epilepsy).
Additional inclusion criteria for T1D disease population:
- Acute disease: - Hyperglycemia and/or pH (venous) <7.3, bicarbonate >10 mmol/L, increased levels of acetone in blood or urine in the context of newly diagnosed or known T1D.
- Chronic disease: - Confirmed diagnosis of T1D
- Physical or intellectual impairment precluding protocol adherence.
Additional exclusion criteria for respiratory disease population:
- Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical and/or pharmacological treatment and is associated with an inflammatory response, relevant congenital defects
Additional exclusion criteria for neurological disease population:
- Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), known inflammatory diseases (e.g. autoimmune disease) that require medical and/or pharmacological treatment and is associated with an inflammatory response, relevant congenital defects.
Additional exclusion criteria for T1D population:
- Known malignancy, active smoker (passive smoke exposure is not an exclusion criterium), relevant congenital defects.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description pneumonia Off-line breath analysis - obstructive bronchitis/bronchiolitis Blood analysis - asthma Blood analysis - neurological diseases Off-line breath analysis - type 1 diabetes (T1D) Real-time SESI-MS breath analysis - obstructive bronchitis/bronchiolitis Off-line breath analysis - pharmacotherapy with antiviral medication Blood analysis - pharmacotherapy with antiepileptic medication Real-time SESI-MS breath analysis - obstructive bronchitis/bronchiolitis Real-time SESI-MS breath analysis - pneumonia Real-time SESI-MS breath analysis - neurological diseases Real-time SESI-MS breath analysis - pneumonia Blood analysis - asthma Off-line breath analysis - type 1 diabetes (T1D) Urine analysis - pharmacotherapy with bronchodilators Off-line breath analysis - asthma Real-time SESI-MS breath analysis - neurological diseases Blood analysis - type 1 diabetes (T1D) Saliva analysis - pharmacotherapy with antibiotics Real-time SESI-MS breath analysis - type 1 diabetes (T1D) Off-line breath analysis - pharmacotherapy with bronchodilators Real-time SESI-MS breath analysis - pharmacotherapy with antibiotics Blood analysis - type 1 diabetes (T1D) Blood analysis - pharmacotherapy with bronchodilators Blood analysis - pharmacotherapy with antibiotics Off-line breath analysis - pharmacotherapy with antiviral medication Off-line breath analysis - pharmacotherapy with antifungal medication Real-time SESI-MS breath analysis - pharmacotherapy with antiviral medication Real-time SESI-MS breath analysis - pharmacotherapy with antifungal medication Off-line breath analysis - pharmacotherapy with antifungal medication Blood analysis - pharmacotherapy with anesthesia (including sedating, analges Real-time SESI-MS breath analysis - pharmacotherapy with antiepileptic medication Off-line breath analysis - pharmacotherapy with immuno suppressants and immune-modulati Off-line breath analysis - pharmacotherapy with antiepileptic medication Blood analysis - pharmacotherapy with immuno suppressants and immune-modulati Real-time SESI-MS breath analysis - pharmacotherapy with immuno suppressants and immune-modulati Blood analysis - pharmacotherapy with anesthesia (including sedating, analges Off-line breath analysis - pharmacotherapy with anesthesia (including sedating, analges Blood analysis -
- Primary Outcome Measures
Name Time Method Days of hospitalization approx 30 days (from beginn hospitalisation to discharge date) In the presentation of an acute disease the primary outcome will be days of hospitalization and its association with the exhaled breath pattern.
Change in Mass spectrometric profile of exhaled breath patterns Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10) In the chronic presentation of the diseases, the mass spectrometric profile of exhaled breath patterns is analyzed
Change in Concentration of exhaled metabolites of pharmacotherapy Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10) Concentration of exhaled metabolites of pharmacotherapy (breath metabolomics data)
- Secondary Outcome Measures
Name Time Method Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l) 0h, 2h, 4h, 6h, 8h, 12h, 18h, 24h, 36h, 48h, 72h (h =hours after hospital admission) Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l)
Change in clinical endpoint lung function (Forced Expiratory Pressure in 1 Second FEV1 l/s) for correlation between clinical endpoint and the abundance of exhaled metabolites approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits) Change in clinical endpoint lung function (Forced Expiratory Pressure in 1 Second FEV1 l/s) for correlation between clinical endpoint and the abundance of exhaled metabolites
Identification of chemical structure of exhaled molecules (acetone, glucose) approx 30 days (from begin hospitalisation to discharge date) Identification of chemical structure of exhaled molecules (acetone, glucose)
Change in clinical endpoint (body temperature, Celsius) for correlation between clinical endpoint and the abundance of exhaled metabolites approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits) Change in clinical endpoint (body temperature) for correlation between clinical endpoint and the abundance of exhaled metabolites
Change in clinical endpoint (blood pressure, mmHg) for correlation between clinical endpoint and the abundance of exhaled metabolites approx 10 years (from begin hospitalisation to discharge date and from first regular clinic visit to Follow-up visits) Change in clinical endpoint (blood pressure) for correlation between clinical endpoint and the abundance of exhaled metabolites
Trial Locations
- Locations (1)
University Children's Hospital Basel (UKBB)
🇨🇭Basel, Switzerland