E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colonisation and Infection with (multi drug resistant) Gram negative bacteria in ICU patients |
Colonización e infección con bacterias por gram negativos multirresistentes en pacientes ingresados en UCI |
|
E.1.1.1 | Medical condition in easily understood language |
Infections caused by these bacteria in ICU patients |
Infecciones causadas por estas bacterias en pacientes de la UCI |
|
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 determine the ecological effects of decolonisation regimens (SDD, SOD and CHX-Oro) in reducing (MDR-GNB) ICU-acquired bacteremia when compared to standard care |
Para determinar los efectos ecológicos de los regímenes de Descolonización (SDD, SOD y CHX-Oro) en la reducción de bacteriemia adquirida en el ICU (MDR-GNB) en comparación con la atención estándar |
|
E.2.2 | Secondary objectives of the trial |
- To quantify cross-transmission rates with MDR-GNB during 3 decolonisation regimens and during standard care. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing acquired respiratory tract colonisation with MDR-GNB - To quantify the effects of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patients on overall systemic antibiotic use. - To quantify on ICU level the associations between intestinal and respiratory tract colonisation with GNB and the occurrence of ICU-acquired GNB bacteraemia. - To quantify species-specific nosocomial transmission capacities of MDR-GNB during 3 decolonisation regimens. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing day-28 and in hospital mortality - To determine ICU-acquired bacteraemia rates caused by any multi-drug resistant micro-organism, during each phase of the study. |
Cuantificar las tasas de transmisión con MDR-GNB durante 3 regímenes de descolonización y atención estándar. -Para determinar la efectividad de los regímenes de descolonización 3 (SDD, SOD y CHX-Oro) en la reducción de la colonización del tracto respiratorio con MDR-GNB adquirido -Cuantificar los efectos de los regímenes de descolonización 3 (SDD, SOD y CHX-Oro) en los pacientes de ICU en el uso de antibióticos sistémico en general. -Cuantificar el nivel de ICU las asociaciones entre la colonización del tracto intestinal y respiratorio con GNB y la aparición de bacteriemia adquirida en el ICU GNB. -Cuantificar las capacidades de la transmisión nosocomial específicos de MDR-GNB durante 3 regímenes de descolonización.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients admitted to the Intensive Care Unit and - mechanically ventilated (invasive or non invasive mechanical ventilation)
with an expected duration of mechanical ventilation > 24 hours |
Pacientes ingresados en la unidad de cuidados intensivos y -ventilación mecánica (invasiva o no invasiva ventilación mecánica) con una duración prevista de la ventilación mecánica superior a 24 horas |
|
E.4 | Principal exclusion criteria |
- preganancy - <18 years old - known allergy to any of the medications or agents used |
-embarazo - menores de 18 años -alergia conocida a alguno de los medicamentos o agentes usados |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To determine the ecological effects on MDR-GNB of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patient |
Para determinar los efectos ecológicos en MDR-BNG de 3 regímenes de Descolonización (SDD, SOD y CHX-Oro) en paciente ICU |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Endpoint will be determined at discharge of the patient from the ICU |
Criterio de evaluación se determinará al alta del paciente de la UCI |
|
E.5.2 | Secondary end point(s) |
- To quantify cross-transmission rates with MDR-GNB during 3 decolonisation regimens and during standard care. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing acquired respiratory tract colonisation with MDR-GNB when compared to standard care. - To quantify the effects of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in ICU patients on overall systemic antibiotic use when compared to standard care. - To quantify on ICU level the associations between intestinal and respiratory tract colonisation with GNB and the occurrence of ICU-acquired GNB bacteraemia. - To quantify species-specific nosocomial transmission capacities (reproductive number per hospital admission, RA) of MDR-GNB during 3 decolonisation regimens and during standard care. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing day-28 mortality and in hospital mortality when compared to standard care. - To determine the effectiveness of 3 decolonisation regimens (SDD, SOD and CHX-Oro) in reducing ICU-acquired bacteraemia when compared to standard care (SC). - To determine ICU-acquired bacteraemia rates caused by any multi-drug resistant micro-organism, including MRSA, VRE, MDR-GNB, Acinetobacter, S. maltophilia, and ceftazidime- and/or carbapenem resistant P. aeruginosa, during each phase of the QIP |
Cuantificar las tasas de transmisión de la Cruz con MDR-GNB durante 3 regímenes de descolonización y atención estándar. -Para determinar la efectividad de los regímenes de descolonización 3 (SDD, SOD y CHX-Oro) en la reducción de adquirió la colonización del tracto respiratorio con MDR-GNB en comparación con la atención estándar. -Cuantificar los efectos de los regímenes de descolonización 3 (SDD, SOD y CHX-Oro) en los pacientes de ICU sobre uso de antibióticos sistémico en general cuando se compara con la atención estándar. -Cuantificar el nivel de ICU las asociaciones entre la colonización del tracto intestinal y respiratorio con GNB y la aparición de bacteriemia adquirida en el ICU GNB. -Cuantificar las capacidades de la transmisión nosocomial específicos (número reproductivo por hospitalización, RA) de MDR-GNB durante 3 regímenes de descolonización y atención estándar. -Determinar la efectividad de 3 regímenes Descolonización (SDD, SOD y CHX-Oro) para reducir la mortalidad del día-28 y en la mortalidad hospitalaria en comparación con la atención estándar. -Determinar la efectividad de los regímenes de descolonización 3 (SDD, SOD y CHX-Oro) en la reducción de bacteriemia adquirida en el ICU en comparación con la atención estándar (SC). -Determinar las tasas de bacteriemia ICU-adquirida causadas por cualquier microorganismo resistente a múltiples droga, incluyendo MRSA, VRE, MDR-BNG, Acinetobacter, S. maltophilia y ceftazidime-andor carbapenem resistente a p. aeruginosa, durante cada fase del QIP |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
all secondary endpoints will be determined on discharge of the participant from the ICU, except for 28th day mortality, which will be determined on day 28 after ICU admission. |
todos los objetivos secundarios se determinarán en el alta del participante de la UCI, excepto la mortalidad día 28, que se determinará en el día 28 después de la admisión de ICU. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
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 | 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 | 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 | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Cluster (cluster = ICU) randomised trial with cross over of interventions within each cluster |
Cluster (cluster = ICU) randomised trial with cross over of interventions within each cluster |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard care |
Standard care |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 | Yes |
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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |