E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Derrame pleural paraneumónico complicado |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014568 |
E.1.2 | Term | Empyema |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10035664 |
E.1.2 | Term | Pneumonia |
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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 |
Comparar la eficacia de dos formas de tratamiento, una farmacológica y otra quirúrgica, para el drenaje del derrame paraneumónico tabicado en niños |
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E.2.2 | Secondary objectives of the trial |
Comparar la Duración de la hospitalización después del tratamiento, el número de días totales de hospitalización, el número de días de drenaje, el número de días con fiebre, la tasa de fracasos y las complicaciones en niños con empiema paraneumónico complicado sometidos a tratamiento de drenaje inicial con UK o VATS |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Edad ≤ 15 años Neumonía con fiebre persistente Derrame pleural paraneumónico complicado demostrado mediante la radiología simple de tórax y mediante la demostración ecográfica de la presencia de líquido ecogénico y tabiques |
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E.4 | Principal exclusion criteria |
Patología preexistente: parálisis cerebral, cardiopatía congénita, cirugía cardiaca o torácica previa en el hemitórax afectado, inmunodeficiencia, traumatismo torácico significativo durante los 2 últimos meses. Pacientes tratados mediante drenaje en el hospital de origen. No será motivo de exclusión el que se haya realizado una toracocentesis diagnóstica previamente, sin intención de evacuar el derrame. Trombopenia o alteraciones de la coagulación. Trastorno hemorrágico significativo actual o en los últimos 6 meses. Hipertensión arterial no controlada grave. Empiema tuberculoso Neumotórax previo al tratamiento
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E.5 End points |
E.5.1 | Primary end point(s) |
Número de días en el hospital después de la intervención. Se calcula desde el día en que se realiza el procedimiento (drenaje más uroquinasa o VATS) hasta el día en que el paciente es dado de alta |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | 8 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |