Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents (EBECA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,600
- 试验地点
- 2
- 主要终点
- Days of hospitalization
研究概览
简要总结
This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Days of hospitalization
时间窗: 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
时间窗: 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
时间窗: Week 0 (first regular clinic visit) to Follow-up visits (approx. years 1-10)
Concentration of exhaled metabolites of pharmacotherapy (breath metabolomics data)
次要结局
- 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))
- 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))
- Identification of chemical structure of exhaled molecules (acetone, glucose)(approx 30 days (from begin hospitalisation to discharge date))
- 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 (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))