E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intra-abdominal abscesses |
Abcesos intraabdominales |
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E.1.1.1 | Medical condition in easily understood language |
Intra-abdominal abscesses |
Abcesos intraabdominales |
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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 |
Determine the clinical response of the addition of local antibiotic therapy to the standard treatment of intra-abdominal abscesses |
Determinar la respuesta clínica de la adición de antibioterapia local al tratamiento estándar de los abscesos intraabdominales. |
|
E.2.2 | Secondary objectives of the trial |
- Determine the time until microbiological eradication / negativization of cultures in the groups under study - Study the development of clinical complications: severe sepsis, kidney failure, others. - To establish if local antibiotic therapy addition reduces the risk of subsequent invasive or surgical procedures; such as: percutaneous drains, endoscopic drainage or open laparotomy. - Assess systemic antimicrobial use by episode |
− Determinar el tiempo hasta la erradicación microbiológica /negativización de los cultivos en los grupos a estudio − Estudiar el desarrollo de complicaciones clínicas: sepsis grave, insuficiencia renal, otras. − Establecer si la adición de antibioterapia local reduce el riesgo de procedimientos invasivos o quirúrgicos subsecuentes; tales como: drenajes percutáneos, drenajes vía endoscópica o laparotomía abierta. − Valorar el consumo de antimicrobianos por vía sistémica por episodio |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- to be 18 years old or more - Intra-abdominal abscesses of any etiology that require drainage catheter placement - Signature of the specific Informed Consent of the trial |
- Edad igual o superior a 18 años - Abscesos intraabdominales de cualquier etiología que requieran colocación de catéter de drenaje - Firma del Consentimiento Informado específico del ensayo. |
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E.4 | Principal exclusion criteria |
- Need for early open surgery (laparotomy) - Patients with systemic embolisms or multiple foci of infection - Impossibility of performing antibiotic sealing for at least 3-4 hours continuously if an antibiotic with activity is used time-dependent - Pregnant women |
- Necesidad de cirugía abierta (laparotomía) temprana - Pacientes con embolismos sistémicos o múltiples focos de infección - Imposibilidad de realizar sellado antibiótico durante al menos 3-4 horas de forma continua si se emplea un antibiótico con actividad tiempo-dependiente - Mujeres embarazadas |
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E.5 End points |
E.5.1 | Primary end point(s) |
Better clinical response with the addition of local antibiotic therapy to the standard treatment of intra-abdominal abscesses. |
Mejor respuesta clínica con la adición de antibioterapia local al tratamiento estándar de los abscesos intraabdominales. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
An evaluation of the end of treatment will be carried out and 1 month after the last administration of the antibiotic. |
Se realizará una evaluación de fin de tratamiento y a 1 mes después de la última administración del antibiótico. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | Yes |
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 | 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 |
Se compararán los mismos antimicrobianos en diferentes formas de uso |
Same antimicrobials will be compared in different ways of use |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |