E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tratamiento de candidiasis Invasiva en paciente adulto no neutropenico. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042938 |
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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 |
Describir el perfil farmacocinético de Anidulafungina en pacientes críticos sometidos a hemodiafiltración confirmando que no se requiere ajustar la dosis del fármaco. |
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E.2.2 | Secondary objectives of the trial |
El estudio pretende confirmar además los datos existentes de que anidulafungina no precisa ajuste de dosis en pacientes críticos sometidos a hemodiálisis2,3 o hemodiafiltración. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Pacientes mayores de 18 años 2- Pacientes que por criterio de su médico requieran ser sometidos a Técnicas de Hemodiafiltración. 3- Firma del Consentimiento informado por parte del paciente o de un familiar. 4- Paciente que requiera tratamiento antifúngico con anidulafungina El paciente ha de recibir un mínimo de dos dosis de anidulafungina antes de poder iniciar el proceso de extracción de muestras el tercer día. (el primer día recibirá una dosis de 200 mg de carga de anidulafungina y el segundo una dosis de 100 mg de mantenimiento de anidulafungina). En caso de obtenerse las muestras otro día posterior al tercero, es indispensable que haya recibido correctamente y sin ninguna falta, todas las dosis anteriores de carga y mantenimiento de anidulafungina. |
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E.4 | Principal exclusion criteria |
1- No cumplir alguno de los criterios de inclusión en el estudio. 2- Hipersensibilidad a anidulafungina 3- Hipersensibilidad a cualquier fármaco de la familia de las equinocandinas 4- Intolerancia a la fructosa |
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E.5 End points |
E.5.1 | Primary end point(s) |
La descripción de la farmacocinética de anidulafungina en paciente critico sometido a técnicas de hemodiafiltración, confirmando la no necesidad de ajuste de dosis de anidulafungina cuando se administra a este tipo de pacientes. |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |