E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pharmacokinetics in critically ill |
Farmakokinetika u kriticky nemocných pacientů |
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E.1.1.1 | Medical condition in easily understood language |
Pharmacokinetics in critically ill |
Farmakokinetika u kriticky nemocných pacientů |
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E.1.1.2 | Therapeutic area | Not possible to specify |
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 |
Determination of colistin and colistin methanesulphonate plasma concentrations in critically ill patients with and without ECMO over the dosing interval. Calculation of plasma colistin AUC. Comparison of pharmacokinetic parameters of CMS and colistin in patients with and without ECMO. To design a model of colistin population pharmacokinetics in critically ill patients. In addition to the effect of ECMO, the effect of other variables will be evaluated - especially creatinine clearance, renal replacement, current or adjusted patient weight. |
Stanovení plazmatických koncentrací colistinu a CMS u kriticky nemocných pacientů s a bez ECMO v průběhu dávkovacího intervalu. Výpočet AUC plazmatických koncentrací colistinu. Srovnání farmakokinetických parametrů CMS a colistinu u pacientů s a bez ECMO. Navrhnout model populační farmakokinetiky colistinu u kriticky nemocných pacientů. Kromě vlivu ECMO bude hodnocen vliv dalších proměnných - především kreatininová clearance, náhrada funkce ledvin, aktuální nebo adjustovaná hmotnost pacienta. |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Neaplikovatelné |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age ≥ 18 years - men and women (negative pregnancy test WOCB) - the patient is admitted to the Department of Anaesthesiology and Resuscitation in St. Anne's University Hospital - parenteral colistin therapy (CMS) in patients with severe bacterial infection - given informed consent according to section 9 of the protocol
Additional inclusion criteria for a subset of patients: the patient on ECMO as part of standard therapy for severe respiratory failure |
- věk ≥ 18 let - muži a ženy (negativní těhotenský test u fertilních žen) - pacient v péči ARK FNUSA - parenterální terapie colistinem (CMS) u pacientů se závažnou bakteriální infekcí - udělen informovaný souhlas dle sekce 9 protokolu
Doplňující zařazovací kritérium pro část pacientů: nutnost připojení pacienta k okruhu ECMO v rámci standardní terapie těžkého respiračního selhání
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E.4 | Principal exclusion criteria |
- the patient refuses to sign the informed consent (either primarily or after regaining consciousness) - pregnancy - breast-feeding |
- pacient odmítne podepsat informovaný souhlas (ať už primárně, anebo po znovunabytí vědomí) - těhotenství - kojení |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Colistin and colistin methanesulphonate (CMS) plasma concentration at predetermined time intervals. - Estimated area under the curve (AUC) of plasma concentrations of colistin and CMS. - Comparison of pharmacokinetic parameters of CMS and colistin. |
- Plazmatická koncentrace kolistinu a kolistinu methansulfonátu (CMS) v předem stanovených časových intervalech. - Odhad plochy pod křivkou (AUC) plazmatických koncentrací colistinu a CMS. - Srovnání farmakokinetických parametrů CMS a colistinu.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 minutes, 2 hours, 6 hours, and 11 hours 50 minutes after starting the 30-minutes i.v. infusion of CMS in patients requiring continuous renal replacement therapy, 30 minutes, 2 hours, and 7 hours 50 minutes after starting the 30-minutes i.v. infusion of CMS |
30 minut, 2 hodiny, 6 hodin a 11 hodin 50 minut po zahájení 30minutové i.v. infuze CMS u pacientů vyžadujících metody náhrady funkce ledvin budou intervaly následující: 30 minut, 2 hodiny a 7 hodin 50 minut po zahájení 30minutové i.v. infuze CMS |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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discontinuation of colistin therapy |
ukončení terapie colistinem |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |