E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Suspected or prophylaxis of invasive aspergillosis. |
Verdenking op of voorkomen van invasieve aspergillose. |
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E.1.1.1 | Medical condition in easily understood language |
Suspected or prophylaxis of invasive fungal infection. |
Verdenking op of voorkoming van invasieve schimmelinfectie. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 |
The main objective is determining the bioavailability of voriconazole in ICU patients. Bioavailability will be calculated by determining the AUC of an intravenous and the AUC of an oral dose of voriconazole. |
Het primaire doel van deze studie is het bepalen van de biologische beschikbaarheid van voriconazol in IC patiënten. De biologische beschikbaarheid wordt bepaald door de AUC van een intraveneuze gift en een orale gift van voriconazol te bepalen. |
|
E.2.2 | Secondary objectives of the trial |
To get an indication of the influence of disease severity, determined with the APACHE IV score, and the degree of inflammation, determined with CRP, on the bioavailability of voriconazole. |
Een indicatie krijgen wat de invloed is van ziekte ernst, bepaald met de APACHE IV score, en de mate van inflammatie, bepaald met CRP, op de biologische beschikbaarheid. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Aged ≥ 18 yrs;
Treatmen with VCZ;
Admission to an ICU;
Written informed consent.
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Ouder dan 18 jaar;
Behandeling met voriconazol;
Opname op de intensive care;
Getekend toestemmingsformulier. |
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E.4 | Principal exclusion criteria |
Blood sampling by central venous catheter or peripheral cannula not possible;
Concomitantly using a strong inhibitor or inducer of CYP P450. |
Afname bloedmonsters via een arterielijn of perifere canule niet mogelijk;
Gelijktijdig gebruik van een sterke CYP450 inductor of remmer |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Bioavailability < 80%, calculated using the area under the concentration time curve (AUC) of an intravenous an oral dose of voriconazole, is considered to be an important clinical difference.
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Biologische beschikbaarheid < 80%, bepaald met behulp van de AUC van een intraveneuze en orale gift van voriconazol, wordt als een belangrijke klinisch verschil gezien. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 hours after administration of an intravenous and oral dose of voriconazole, wherein the patient received at least four doses of voriconazole. |
24 uur na toediening van een intraveneuze en orale gift van voriconazol, waarbij de patiënt tenminste vier giften voriconazol heeft gekregen. |
|
E.5.2 | Secondary end point(s) |
To get an indication of the influence of disease severity, determined with the APACHE IV score, and the degree of inflammation, determined with CRP, on the bioavailability of voriconazole. |
Een indicatie krijgen wat de invloed is van ziekte ernst, bepaald met de APACHE IV score, en de mate van inflammatie, bepaald met CRP, op de biologische beschikbaarheid. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
24 hours after administration of an intravenous and oral dose of voriconazole, wherein the patient received at least four doses of voriconazole. |
24 uur na toediening van een intraveneuze en orale gift van voriconazol, waarbij de patiënt tenminste vier giften voriconazol heeft gekregen. |
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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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
In plaats van een orale gift, krijgt een patiënt eenmalig een intraveneuze gift voriconazol. |
Instead of an oral dose, a patient receives one intravenous dose of voriconazole. |
|
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
|
24 hours after the last patient is included. |
24 uur nadat de laatste patiënt is geïncludeerd. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |