E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients admitted to the paediatric intensive care unit with single-organ respiratory failure |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- what are the pharmacokinetic parameters (distribution volume, distribution half-life, terminal half-life, context-sensitive half-life, clearance) of dexmedetomidine infusion in mechanically ventilated children with single-organ respiratory failure? - do size, age, co-medication, severity of illness, infusion length (covariates) contribute to a variability in exposure and response to dexmedetomidine in this population? - knowledge of the pharmacokinetic parameters of dexmedetomidine and their covariates will allow targeted dosing in children |
|
E.2.2 | Secondary objectives of the trial |
- does CYP2A6 and UDP-glucuronosyltransferase genotype (covariates) contribute to a variability in exposure and response to dexmedetomidine in this population? |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- patients admitted to the paediatric intensive care unit - expected to require at least 24h of mechanical ventilation - patient age : 1 month-15 years - patients with single-organ respiratory failure
|
|
E.4 | Principal exclusion criteria |
- patients with neurologic conditions that prohibit an evaluation of adequate analgosedation - no arterial catheter in place at inclusion - patients who have received another investigational drug within 30 days - patients on continuous infusion with neuromuscular blockers - patients with a life expectancy <72h - patients with a known allergy to lorazepam, midazolam and/or morphine - heart block - pre-existing bradycardia - hemodynamically unstable patients (Wernovsky index > 16 points) after full fluid replacement with cristalloid - paients with significant renal insufficiency (creatinine plasma level 1 month-5 year : > 1 mg/dl ; 5-10 years : >1.2 mg/dl; > 10 years : > 1.5 mg/dl) - patients with significant hepatic insufficiency (aspartate aminase >950 UI/L and prothrombin time < 60 or INR >1.4) - previous treatment with α2-adrenoreceptor agonist clonidine within 14 days |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |