E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Peritonitis bacteriana espontánea en pacientes con cirrosis con alto y bajo riesgo de desarrollar complicaciones |
|
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 study if oral norfloxacin added to standard antibiotic treatment (intravenous cefotaxime) improves survival of cirrhotic patients with Spontaneus Bacterial Peritonitis. |
|
E.2.2 | Secondary objectives of the trial |
to study if oral norfloxacin added to standard antibiotic treatment (intravenous cefotaxime) decreases associated complications (hepatorenal syndrome, acute-on-chronic liver failure), and episodes of bacterial translocation that takes place during the usual i.v. antibiotic treatment. Also, length of hospitalisation, complications in a 3-month period after discharge and cost-efficacy will be evaluated. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Pacientes cirróticos con ascitis y con más de 250 polimorfonucleares/mm3 sin signos sugestivos de peritonitis secundaria 2- Hombres y mujeres. Las mujeres deben ser estériles quirúrgicamente o ser postmenopáusicas 3- Edades entre 18 y 80 años 4- Aceptación libre de participar en el ensayo, con consentimiento informado por escrito del paciente |
|
E.4 | Principal exclusion criteria |
1. Tratamiento antibiótico sistémico en la semana previa al diagnóstico de la Peritonitis bacteriana espontánea (incluido norfloxacino profiláctico) 2. Infecciones distintas de la PBE 3. Necesidad de uso de una pauta antibiótica distinta, de fármacos vasoactivos o de ingreso en UCI (Datos clínicos y/o hemodinámicos sugestivos de sepsis grave o shock séptico) 4. Hemorragia gastrointestinal activa o en los últimos 7 días 5. Encefalopatía hepática grado 3 o 4 6. Creatinina sérica > 3 mg/dL 7. Insuficiencia cardiaca descompensada 8. Hallazgos sugestivos de nefropatía orgánica (proteinuria, hematuria,...) 9. Infección VIH 10. Enfermedades, distintas de la cirrosis y PBE, que a juicio del clínico responsable puedan comprometer el pronóstico a corto plazo, tales como hepatocarcinoma avanzado. 11. Sujetos incapaces de dar su consentimiento informado. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mortalidad por cualquier causa durante la hospitalización |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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 | 9 |
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
| |
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |