E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
S Aureus bacteraemia (indirectly) |
S Aureus bacteriemie ( indirect) |
|
E.1.1.1 | Medical condition in easily understood language |
blood infection with S Aureus ( indirectly) |
S aureus infectie in het bloed (indirect) |
|
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 |
Our aim is to evaluate whether the current flucloxacillin absorption test is able to adequately predict the absorption of flucloxacillin compared to an absorption test after switch. |
Ons doel is om te kijken of de huidige flucloxacilline absorptietest de absorptie van flucloxacilline goed voorspelt tov van een absorptie test uitgevoerd na overgang op oraal flucloxacilline |
|
E.2.2 | Secondary objectives of the trial |
Our secondary objective is to identify co-variants in order to improve the predictability, optimize and/or simplify the test. |
Het identificeren van co-varianten om de voorspelbaarheid van de absorptie van test te verbeteren en de test optimalizeren dan wel versimpelen. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
>18 years
Admitted to the hospital
S aureus infection with continuous infusion of flucloxacillin
Clinically eligible to be switched to oral flucloxacillin
|
>18 years
Opgenomen in het ziekenhuis
S aureus infectie waarvoor flucloxacilline per continu infuus
komt klinisch in aanmerking om te switchen naar oraal |
|
E.4 | Principal exclusion criteria |
ICU admittance
Pregnancy
|
IC opname
zwangerschap |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The prediction of time above MIC of both the 3 point concentration curves and 7 point concentration curves per patient before and after switch to oral flucloxacillin will be compared. > 50% time above MIC is considered sufficient |
De tijd boven de de MIC van zowel de 3 als 7 punts curves zowel voor als na switch zullen per patient worden vergeleken.> 50% tijd boven MIC wordt als voldoende beschouwd |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
not applicable |
niet van toepassing |
|
E.5.2 | Secondary end point(s) |
Population pharmacokinetic analysis will be performed by use of NONMEM to develop an integrated model for total and free concentration en covarianten |
populatie farmacokinetiek zal worden uitgevoerd dmv NONMEM om een geintergreerd model te mken voor totale en vrije fractie en covarianten |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
niet van toepassing |
|
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 | 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 | 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
|
this study will last one year or shorter if before one year inclusion has been reached |
een jaar of korter als de inclusie eerder gehaald wordt |
|
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 | |