Development of Antimicrobial Defined Daily Dose (DDD) for the Pediatric Population.

Antimicrobial stewardship programs (ASPs) optimize antimicrobial use, improve patient outcomes, and reduce resistance. To assess the effectiveness of ASPs, it is necessary to have indicators that can be widely used. Defined daily dose (DDD) was designed by WHO for the adult population as a consumption indicator. However, there are no DDDs adapted to the pediatric population. The main objective of this study is to establish the most appropriate DDD values in this population. An observational, retrospective, multicenter study was conducted. Antimicrobial prescriptions were collected from pediatric wards of seven Spanish tertiary hospitals for 2 years. The DDDs obtained from the prescriptions were compared with the theoretical DDDs agreed upon in the first stage. To select the optimal DDD, the following were analyzed: power value, magnitude obtained from the differences in the DDD, statistical significance, and degree of agreement in the stipulated doses. A total of 4788 prescriptions were collected. Pediatric DDD was defined for 30 different antimicrobials. A potency >80% was obtained in 24 antibiotics. 51.2% of the selected DDD correspond to Phase I and 39.5% from Phase II. Pediatric DDD of different antimicrobials was obtained, providing an indicator that can be used globally in different hospitals to analyze the consumption and efficacy of ASPs.

Antimicrobial defined daily dose adjusted by weight: a proposal for antibiotic consumption measurement in children / Dosis diaria definida ajustada por peso: una propuesta para la medición de consumo antimicrobiano en pediatría

INTRODUCTION: Antimicrobial defined daily dose (DDD), has limitations for antimicrobial consumption measurement in paediatrics. An alternative DDD design applicable for children is proposed. METHODS: Children (< 16 years-old) from 10 Spanish hospitals during a 12-months period were included. Weight for age (50th percentile) was calculated for the median age of the cohort using standardized World Health Organization tables. DDD (g) for each antimicrobial was calculated by multiplying the obtained weight times the recommended dose (mg/kg) of the antimicrobial for the most common infectious indication. RESULTS: A total of 40,575 children were included. Median age was 4.17 (IQR: 1.36-8.98) and 4.81 (IQR: 1.42-9.60) years for boys and girls, respectively. Mean weight for this age was 17.08 kg. Standardized DDD for representative antimicrobials were calculated. CONCLUSIONS: A useful method for antimicrobial DDD measurement in paediatrics has been proposed and should be validated in future studies for its use in paediatric antimicrobial stewardship programmes

INTRODUCCIÓN: La dosis diaria definida (DDD), tiene limitaciones para la medición del consumo antimicrobiano en pediatría. Se propone un diseño aplicable en niños. MÉTODOS: Se incluyeron niños (< 16 años) de 10 hospitales españoles durante un periodo de 12 meses. A partir de la mediana de edad de la cohorte, utilizando tablas estandarizadas de la OMS, se obtuvo el peso correspondiente al percentil P50 de esa edad. Se calculó la DDD (gr) multiplicando el peso obtenido por la dosis recomendada (mg/kg) de cada antimicrobiano para su indicación más común. RESULTADOS: Un total de 40575 niños fueron incluidos. La mediana de edad fue 4,17 (RIQ: 1,36-8,98) y 4,81 (RIQ: 1,42-9,60) años para niños y niñas, respectivamente. Peso medio para la edad: 17,08 kg. DDD estandarizadas fueron calculadas para antimicrobianos representativos. CONCLUSIONES: Se ha propuesto un método útil para monitorizar consumo antimicrobiano en pediatría utilizando DDD adaptadas, que deberá validarse en futuros estudios

Antimicrobial defined daily dose adjusted by weight: a proposal for antibiotic consumption measurement in children.

INTRODUCTION: Antimicrobial defined daily dose (DDD), has limitations for antimicrobial consumption measurement in paediatrics. An alternative DDD design applicable for children is proposed. METHODS: Children (<16 years-old) from 10 Spanish hospitals during a 12-months period were included. Weight for age (50th percentile) was calculated for the median age of the cohort using standardized World Health Organization tables. DDD (g) for each antimicrobial was calculated by multiplying the obtained weight times the recommended dose (mg/kg) of the antimicrobial for the most common infectious indication. RESULTS: A total of 40,575 children were included. Median age was 4.17 (IQR: 1.36-8.98) and 4.81 (IQR: 1.42-9.60) years for boys and girls, respectively. Mean weight for this age was 17.08kg. Standardized DDD for representative antimicrobials were calculated. CONCLUSIONS: A useful method for antimicrobial DDD measurement in paediatrics has been proposed and should be validated in future studies for its use in paediatric antimicrobial stewardship programmes.

Hierro intravenoso, recuperación funcional y delirium en pacientes con fractura de cadera. Estudio FEDEREF. Ensayo clínico unicéntrico aleatorizado, controlado con placebo, doble ciego. Número EudraCT: 2014-001923-53 / Intravenous iron, functional recovery and delirium in patients with hip fracture. FEDEREF study. Single-centre randomised, placebo-controlled, and double-blind clinical trial. 2014-001923-53: EudraCT number

Introducción. No existen estudios previos que evalúen el efecto de la ferroterapia intravenosa sobre la situación funcional y cognitiva de pacientes con fractura de cadera (FC). Material y métodos. Ensayo clínico unicéntrico aleatorizado, controlado con placebo, doble ciego en grupos paralelos, para comparar la eficacia del tratamiento con hierro intravenoso perioperatorio en pacientes ancianos intervenidos de FC. Se asegura el enmascaramiento del tratamiento, envolviendo el fármaco y el sistema de infusión. El grupo intervención recibirá, los días 1, 3 y 5 de ingreso, 200mg de Venofer (R ) (hierro sacarosa), diluidos en 100ml de suero salino y el control, 100ml de suero salino los días 1, 3 y 5 de ingreso. Los pacientes reciben la asistencia convencional en la Unidad de Ortogeriatría del Hospital Universitario Infanta Sofía. Para valorar el impacto del tratamiento, se recogen variables funcionales (actividades de la vida diaria y capacidad de deambulación), cognitivas (situación cognitiva previa y delirium), quirúrgicas, demográficas y clínicas durante el ingreso y se realiza un análisis de seguridad del tratamiento. Los pacientes reciben seguimiento a los 3, 6 y 12 meses. Resultados. El estudio reportará evidencia acerca del impacto de la administración de hierro intravenoso sobre la recuperación funcional a corto y medio plazo. Permitirá evaluar si la administración de ferroterapia intravenosa tiene algún efecto negativo sobre la incidencia de delirium postoperatorio. Aportará información acerca de la seguridad de la administración de ferroterapia intravenosa en pacientes ancianos con FC y su repercusión sobre el ahorro transfusional. Conclusiones. La inclusión de los pacientes ancianos con FC ingresados en una unidad de ortogeriatría en el ensayo clínico permitirá la evaluación del impacto del fármaco en un escenario habitual, y aportará datos valiosos para la protocolización de su uso en otras unidades (AU)

Introduction. There are no previous studies evaluating the effect of intravenous iron therapy on functional and cognitive status of patients with hip fracture (HF). Material and methods. A single-centre randomised, placebo-controlled, double-blind and parallel treatment, clinical trial has been designed to assess the efficacy of intravenous iron therapy during the peri-operative period in elderly patients suffering from a HF. Blinding will be ensured by the packaging of the drug infusion system. On days 1, 3, and 5 from admission, the intervention group will receive 200mg Venofer (R ) (iron sucrose) diluted in 100ml saline, and the control group 100ml saline, also on days 1, 3 and 5. Patients will received conventional treatment in ortho-geriatric unit of the Hospital Infanta Sofia. Functional variables (activities of daily living and walking), cognitive (cognitive status and delirium), surgical, demographic and clinical characteristics will be collected during admission in order to assess the impact of treatment. A safety analysis of the treatment will also performed. Patients will be followed-up at 3, 6, and 12 months. Results. The study will attempt to provide evidence on the impact of the intravenous iron administration on functional recovery. It will be determined whether iron therapy negatively affects the incidence of post-operative delirium. Finally, report will be presented on the safety data of intravenous iron in elderly HF patients, as well as the impact on allogenic blood transfusion savings. Conclusions. The inclusion of elderly HF patients admitted to an ortho-geriatric unit, in a clinical trial, will help to improve the knowledge of the treatment impact on a usual scenario, and provide useful data for use in other units (AU)

[Intravenous iron, functional recovery and delirium in patients with hip fracture. FEDEREF study. Single-centre randomised, placebo-controlled, and double-blind clinical trial. 2014-001923-53: EudraCT number]. / Hierro intravenoso, recuperación funcional y delirium en pacientes con fractura de cadera. Estudio FEDEREF. Ensayo clínico unicéntrico aleatorizado, controlado con placebo, doble ciego. Número EudraCT: 2014-001923-53.

INTRODUCTION: There are no previous studies evaluating the effect of intravenous iron therapy on functional and cognitive status of patients with hip fracture (HF). MATERIAL AND METHODS: A single-centre randomised, placebo-controlled, double-blind and parallel treatment, clinical trial has been designed to assess the efficacy of intravenous iron therapy during the peri-operative period in elderly patients suffering from a HF. Blinding will be ensured by the packaging of the drug infusion system. On days 1, 3, and 5 from admission, the intervention group will receive 200mg Venofer® (iron sucrose) diluted in 100ml saline, and the control group 100ml saline, also on days 1, 3 and 5. Patients will received conventional treatment in ortho-geriatric unit of the Hospital Infanta Sofia. Functional variables (activities of daily living and walking), cognitive (cognitive status and delirium), surgical, demographic and clinical characteristics will be collected during admission in order to assess the impact of treatment. A safety analysis of the treatment will also performed. Patients will be followed-up at 3, 6, and 12 months. RESULTS: The study will attempt to provide evidence on the impact of the intravenous iron administration on functional recovery. It will be determined whether iron therapy negatively affects the incidence of post-operative delirium. Finally, report will be presented on the safety data of intravenous iron in elderly HF patients, as well as the impact on allogenic blood transfusion savings. CONCLUSIONS: The inclusion of elderly HF patients admitted to an ortho-geriatric unit, in a clinical trial, will help to improve the knowledge of the treatment impact on a usual scenario, and provide useful data for use in other units.