E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
suspected invasive candidiasis |
verdenking op invasieve candia infectie |
|
E.1.1.1 | Medical condition in easily understood language |
invasive fungal infection |
invasieve schimmel infectie |
|
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 |
Determine the pharmacokinetics of caspofungin, and the optimal dosage of caspofungin at which an adequate exposure is achieved in critically ill patients. |
Het vaststellen van farmacokinetische parameters van caspofungin bij patiënten op de intensive care en het bepalen van de optimale dosering van caspofungin waarbij een adequate blootstelling bereikt wordt bij deze groep patiënten. |
|
E.2.2 | Secondary objectives of the trial |
1) Pharmacokinetic parameters of caspofungin in critically ill patients.
2) Correlation of pharmacokinetic parameters and the plasma
concentration of caspofungin with disease severity scores.
3) Correlation of the plasma concentration of caspofungin with candida eradication.
4) Correlation of the plasma concentration of caspofungin with
inflammation parameters.
5) AUC/MIC ratio and Cmax/MIC ratio.
6) Constructing a pharmacokinetic model of caspofungin in critically ill patients.
7) Drug-related adverse events of caspofungin.
8) The amount of caspofungin that is lost in dialysis. |
1) Farmacokinetische parameters van caspofungin in intensive care
patiënten.
2) Correlatie van de farmacokinetische parameters en de
plasmaconcentratie van caspofungin met ziekte-ernst scores.
3) Correlatie van de plasmaconcentratie van caspofungin met eradicatie van candida.
4) Correlatie van de plasmaconcentratie van caspofungin met
ontstekingsparameters.
5) AUC/MIC ratio en Cmax/MIC ratio.
6) Opstellen van een farmacokinetisch model voor caspofungin in
intensive care patiënten.
7) Bijwerkingen van caspofungin.
8) De hoeveelheid caspofungin die verloren gaat bij dialyse. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Treatment with caspofungin.
Admission to an ICU.
Age ≥ 18 years.
Suspected invasive candidiasis. |
Behandeling met caspofungin.
Opname op de intensive care.
Leeftijd ≥ 18 jaar.
Verdenking op invasieve candida. |
|
E.4 | Principal exclusion criteria |
Blood sampling not possible. |
Afname bloedmonsters niet mogelijk. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The exposure to caspofungin, an AUC of 98 mg*h/L is established as an adequate exposure |
De blootstelling aan caspofungin, een AUC van 98 mg*h/L is vastgesteld als adequate blootstelling. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 3 (± 1 day) of treatment with caspofungin. |
Dag 3 (± 1 dag) van de behandeling met caspofungin. |
|
E.5.2 | Secondary end point(s) |
1) Pharmacokinetic parameters of caspofungin in critically ill patients.
2) Correlation of pharmacokinetic parameters and the plasma
concentration of caspofungin with disease severity scores.
3) Correlation of the plasma concentration of caspofungin with candida eradication.
4) Correlation of the plasma concentration of caspofungin with
inflammation parameters.
5) AUC/MIC ratio and Cmax/MIC ratio.
6) Constructing a pharmacokinetic model of caspofungin in critically ill patients.
7) Drug-related adverse events of caspofungin.
8) The amount of caspofungin that is lost in dialysis. |
1) Farmacokinetische parameters van caspofungin in intensive care
patiënten.
2) Correlatie van de farmacokinetische parameters en de
plasmaconcentratie van caspofungin met ziekte-ernst scores.
3) Correlatie van de plasmaconcentratie van caspofungin met eradicatie van candida.
4) Correlatie van de plasmaconcentratie van caspofungin met
ontstekingsparameters.
5) AUC/MIC ratio en Cmax/MIC ratio.
6) Opstellen van een farmacokinetisch model voor caspofungin in
intensive care patiënten.
7) Bijwerkingen van caspofungin.
8) De hoeveelheid caspofungin die verloren gaat bij dialyse. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) day 3.
2) day 3.
3) day 28.
4) day 3.
5) day 28.
6) day 28.
7) day 28.
8) day 28. |
1) dag 3.
2) dag 3.
3) dag 28.
4) dag 3.
5) dag 28.
6) dag 28.
7) dag 28
8) dag 28. |
|
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 | 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 | 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 |
Dosisaanpassing van caspofungin in geval van onvoldoende blootstelling. |
Dose adjustment of caspofungin in case of inadequate exposure. |
|
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
|
28 days after the last patient is included. |
28 dagen nadat de laatste patient is geincludeerd. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |