Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04461821
Other study ID # 2020-00778; ks20Sinues
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 11, 2020
Est. completion date July 2030

Study information

Verified date February 2024
Source University Children's Hospital Basel
Contact Pablo Sinues, Prof. Dr.
Phone +41 61 704 2949
Email pablo.sinues@ukbb.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.


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 information / eligibility

Status Recruiting
Enrollment 3600
Est. completion date July 2030
Est. primary completion date July 2030
Accepts healthy volunteers No
Gender All
Age group N/A to 22 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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


Intervention

Diagnostic Test:
Real-time SESI-MS breath analysis
Participants will be asked to refrain from eating, drinking, chewing gum use or brushing their teeth at least 1 hour before the measurements will be performed. Room temperature and lighting will be set at the same level for all measurements. Participants will exhale through a disposable mouthpiece into a commercially available SESI source (FIT S.L., Spain). While performing full exhalations, the subjects will keep the pressure through the sampling line at a fixed value monitored by a digital manometer. Breath prints will be collected in real-time recording multiple replicates (typically six in positive and negative ion mode). The whole procedure is absolutely non-invasive and is usually accomplished without any effort in around 15 min per subject.
Off-line breath analysis
In young children below the age of 4 not capable of completing the on-line exhalation maneuvers, or in cases when the patient needs cannot approach the mass spectrometer, the sample will be collected off-line. They will be asked to exhale into a bag that will be transported to the lab and deflated into the mass spectrometer for analysis. Exhaled breath of patients under anesthesia will also collected using available ventilation system in the operation theatre.
Blood analysis
Blood analysis done in patients who undergo regular blood sampling needed for clinical routine laboratory controls. This includes i) children and adolescents receiving medications which require TDM ii) patients with acute diseases such as TD1 and pneumonia and iii) patients with chronic diseases such as asthma bronchiale. For those patients where a blood sample is drawn during the clinical routine, an additional blood sample consisting of only several blood drops will be collected using the same blood sampling line. No additional venous puncture for research purpose will be done.
Saliva analysis
During the diagnostic and therapeutic work-up of T1D patients, saliva samples are collected during the clinical routine. For those patients, additional samples will be obtained by clinically trained investigators.
Urine analysis
During the diagnostic and therapeutic work-up of T1D patients, urine samples are collected during the clinical routine. For those patients, additional samples will be obtained by clinically trained investigators.

Locations

Country Name City State
Switzerland University Children's Hospital Basel (UKBB) Basel

Sponsors (3)

Lead Sponsor Collaborator
University Children's Hospital Basel Fondation Botnar (Switzerland), Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Days of hospitalization In the presentation of an acute disease the primary outcome will be days of hospitalization and its association with the exhaled breath pattern. approx 30 days (from beginn hospitalisation to discharge date)
Primary Change in Mass spectrometric profile of exhaled breath patterns In the chronic presentation of the diseases, the mass spectrometric profile of exhaled breath patterns is analyzed Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)
Primary Change in Concentration of exhaled metabolites of pharmacotherapy Concentration of exhaled metabolites of pharmacotherapy (breath metabolomics data) Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)
Secondary Identification of chemical structure of exhaled molecules (acetone, glucose) Identification of chemical structure of exhaled molecules (acetone, glucose) approx 30 days (from begin hospitalisation to discharge date)
Secondary Correlations of identified molecules (acetone, glucose) in exhaled breath with body fluids (blood, saliva, urine) for T1D acute disease (mmol/l) 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)
Secondary 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 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)
Secondary Change in clinical endpoint (body temperature, Celsius) for correlation between clinical endpoint and the abundance of exhaled metabolites Change in clinical endpoint (body temperature) 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)
Secondary Change in clinical endpoint (blood pressure, mmHg) for correlation between clinical endpoint and the abundance of exhaled metabolites Change in clinical endpoint (blood pressure) 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)
See also
  Status Clinical Trial Phase
Recruiting NCT05653518 - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes N/A
Enrolling by invitation NCT05515939 - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed NCT05109520 - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting NCT04016987 - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes N/A
Active, not recruiting NCT04190368 - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes N/A
Recruiting NCT05413005 - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus Early Phase 1
Active, not recruiting NCT04668612 - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes N/A
Completed NCT02837094 - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1 Phase 1
Recruiting NCT05414409 - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action Phase 2
Recruiting NCT05670366 - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes N/A
Active, not recruiting NCT05418699 - Real-life Data From Diabetic Patients on Closed-loop Pumps
Completed NCT04084171 - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6 N/A
Recruiting NCT06144554 - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Recruiting NCT05153070 - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes Phase 2
Completed NCT05281614 - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D Early Phase 1
Withdrawn NCT04259775 - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes N/A
Active, not recruiting NCT01600924 - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed NCT02897557 - Insulet Artificial Pancreas Early Feasibility Study N/A
Completed NCT02855307 - Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes Phase 2