E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infection |
Infecciones causadas por microorganismos gran positivos multirresistentes |
|
E.1.1.1 | Medical condition in easily understood language |
Infection in the intensive care unit |
Infecciones en las unidades de cuidados intensivos |
|
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 |
To characterize the pharmacokinetics of linezolid when administered by continuous infusion |
Caracterizar la farmacocinética de linezolid tras su administración en infusión continua |
|
E.2.2 | Secondary objectives of the trial |
- To calculate the parameters related to the efficacy and toxicity - To cCompare the results with those obtained after conventional administration |
Calcular los parámetros relacionados con la eficacia y toxicidad Comparar los resultados con los obtenidos tras administración convencional |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Admitted to the intensive care unit. Diagnosis of sepsis. Need to linezolid because of suspected infection due to multiresistant gram positive cocci |
Ingresado en el servicio de medicina intensiva. Diagnóstico de sepsis. Necesidad de linezolid debido a la sospecha de infección por cocos gram positivos multirresistentes |
|
E.4 | Principal exclusion criteria |
Pregnancy. Age <18 years. Severe renal failure |
Embarazo. Edad <18 años. Insuficiencia renal grave. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To compare the efficacy of two different dosage regimen of linezolid |
comparar la eficacia de linezolid con dos regímenes de administración diferente |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
To compare the risk of overexposure of two different dosage regimen of linezolid |
comparar el riesgo de sobreexposición de linezolid con dos regímenes de administración diferente |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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 | 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) | 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 | 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.8.2.4 | Number of treatment arms in the trial | 25 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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
|
The trial will end when the necessary sample size is reached |
El ensayo finalizará cuando se complete el tamaño muestral estimado |
|
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 | |
E.8.9.2 | In all countries concerned by the trial years | 2 |