Study protocol for a randomized clinical trial to assess 7 versus 14-days of treatment for Pseudomonas aeruginosa bloodstream infections (SHORTEN-2 trial).

BACKGROUND: Research priorities in Antimicrobial Stewardship (AMS) have rapidly evolved in the last decade. The need for a more efficient use of antimicrobials have fueled plenty of studies to define the optimal duration for antibiotic treatments, and yet, there still are large areas of uncertainty in common clinical scenarios. Pseudomonas aeruginosa has been pointed as a priority for clinical research, but it has been unattended by most randomized trials tackling the effectiveness of short treatments. The study protocol of the SHORTEN-2 trial is presented as a practical example of new ways to approach common obstacles for clinical research in AMS. OBJECTIVE: To determine whether a 7-day course of antibiotics is superior to 14-day schemes for treating bloodstream infections by P. aeruginosa (BSI-PA). METHODS: A superiority, open-label, randomized controlled trial will be performed across 30 Spanish hospitals. Adult patients with uncomplicated BSI-PA will be randomized to receive a 7 versus 14-day course of any active antibiotic. The primary endpoint will be the probability for the 7-day group of achieving better outcomes than the control group, assessing altogether clinical effectiveness, severe adverse events, and antibiotic exposure through a DOOR/RADAR analysis. Main secondary endpoints include treatment failure, BSI-PA relapses, and mortality. A superiority design was set for the primary endpoint and non-inferiority for treatment failure, resulting in a sample size of 304 patients. CONCLUSIONS: SHORTEN-2 trial aligns with some of the priorities for clinical research in AMS. The implementation of several methodological innovations allowed overcoming common obstacles, like feasible sample sizes or measuring the clinical impact and unintended effects. TRIAL REGISTRATION: EudraCt: 2021-003847-10; ClinicalTrials.gov: NCT05210439.

Trauma por caída de altura en niños que requirieron hospitalización / Trauma for fall of height in children who required hospitalization

Introducción. En Argentina, el trauma es la causa más frecuente de muerte en niños mayores de 1 año, con una elevada morbilidad y un alto costo para el sistema de salud. La caída de altura es la principal causa de lesiones traumáticas luego de los eventos por vehículo a motor. Objetivos. Explorar factores relacionados con traumatismos por caída de altura en pacientes hospitalizados, clasificar sus causas, describir la topografía lesional y analizar factores de riesgo y el evento traumático a través del Índice de Trauma Pediátrico (ITP). Material y métodos. Estudio de sección transversal con posterior tratamiento analítico mediante regresión logística. Se incluyeron 113 niños en forma consecutiva, de 0 a 18 años que requirieron hospitalización por trauma por caída de altura entre el 15 de noviembre de 2014 al 14 de noviembre de 2015, con seguimiento longitudinal hasta el alta. Dentro del universo de niños con trauma, se eligió el subconjunto de pacientes arriba mencionado. Se realizó una entrevista a los padres y se diseñó una ficha médica con datos obtenidos de las historias clínicas. Los pacientes enrolados se dividieron en dos grupos según el Índice de Trauma Pediátrico (ITP) para identificar potenciales factores de riesgo mediante un modelo de regresión logística. Se estratificaron en tres grupos etarios para el análisis de la topografía lesional. Resultados. De los 113 pacientes incluidos en el estudio, el 55,9% las caídas fueron por negligencia, siendo las lesiones más frecuentes el traumatismo encéfalo craneano (TEC) en menores de 3 años y de los miembros en niños mayores; los factores de riesgo identificados fueron el juego durante el evento y la presencia de gas natural, ambos predictores de trauma de menor gravedad. Conclusiones. Se pudo solo determinar la asociación de dos de los factores de riesgo explorados, probablemente relacionados a la n de pacientes en relación a las múltiples variables incluidas. La causa más frecuente de trauma fue por negligencia; el TEC fue la lesión más frecuente en niños pequeños y en los mayores fue el compromiso de miembros en la población estudiada

Introduction. Trauma injuries are the main cause of mortality in children older than 1 year, producing high morbidity and high costs in health system. After motor vehicle-related injuries, falls are the leading cause of unintentional injuries in children. Objectives. To explore factors related to trauma due to height fall in hospitalized patients, to classify the causes of trauma due to height fall, to identify the injuries topography and to analyze the association between risk factors and trauma events using the Pediatric Trauma Index. Methods. In this cross-section study, with posterior logistic regression analysis, one hundred and thirteen children consecutively admitted for trauma due to fall height, from 0 to 18 years old, from November 15th, 2014 to November 14th, 2015 were prospectively evaluated. Parental interviews were conducted, and medical file, based on clinical records was designed. The sample was divided in two groups according to the Pediatric Trauma Index in order to identify risk factors through a logistic regression model. Patients were stratified in 3 age groups for the analysis of lesion topography. Results. Of the 113 patients included, 55.9% of the falls were due to negligence, cranioencephalic trauma (TEC) was the main trauma in children less than 3 years old, and limb fractures predominated in older population. In the multiple regression analysis, the risk factors identified were game activity and gas for home use, both predictors of less severity trauma. Conclusions. We could only determine the association of two of the risk factors explored, probably related to the number of patients in relation to the multiple variables included. We can demonstrate only the association of two of all risk factors explored, probably related with n of patients and the multiple variables included. The most frequent cause of trauma was due to negligence. In the studied population, TEC was the most frequent injury in small children and in the older children the commitment of members

Lesiones no intencionales por vehículos a motor en pediatría. Estudio epidemiológico en pacientes internados en el Hospital de Niños "Ricardo Gutiérrez" / Unintentional injuries by motor vehicles in pediatrics. Epidemiological study of admitted patients to the "Ricardo Gutierrez" Children's Hospital

Introducción: El trauma es la causa más frecuente de muerte en niños mayores de 1 año en Argentina y presenta elevada morbilidad y alto costo para el sistema de salud. Los traumatismos por vehículo a motor (VAM) son una de las causas más frecuentes de lesiones graves. Objetivo: Identificar las causas, cinemática, topografía lesional y analizar el impacto de los factores epidemiológicos relacionados con traumatismos por VAM en pacientes internados en el Hospital de Niños "Ricardo Gutiérrez" (HNRG). Analizar factores de riesgo pasibles de intervención. Métodos: Estudio observacional, prospectivo, analítico y de predictores. Se incluyeron 47 niños de 0 a 18 años, internados por lesiones por VAM entre el 1 de abril de 2015 al 31 de marzo de 2017. Se confeccionó una ficha médica con datos obtenidos de las historias clínicas y entrevista a los padres. Los pacientes se dividieron en tres grupos: pasajeros, peatones y biciclistas. La severidad se valoró según el Índice de Trauma Pediátrico (ITP) en dos grupos para identificar factores de riesgo para trauma grave (ITP≤8) mediante un modelo de regresión logística. Variables predictivas: características demográficas del paciente y sus padres, nivel y factores de riesgo socio-económicos, datos del incidente, asistencia inicial, evolución y su causa. Para analizar la injuria topográfica, se estratificaron tres grupos etarios. Resultados: En el 36.2% la causa del evento fue negligencia. En el 68.1% de los eventos el mecanismo lesional fue atropello. La topografía más frecuente fue Sistema Nervioso Central (SNC) 42.6% aislado y 57.5% asociado a otras lesiones. Se estimó un aumento de la probabilidad de riesgo de ingresar a cuidados intensivos de 15,27 veces, cada vez que ITP pasa de >8 a grave. Conclusiones: En más del 66% de los eventos las causas fueron: negligencia e imprudencia. El mecanismo lesional más frecuente fue el atropello. Los menores de 3 años presentaron trauma aislado de SNC (66%). Los pacientes con ITP bajo presentaron elevada probabilidad de requerir cuidados intensivos. Se recomienda enfatizar en educación, prevención e investigación para generar propuestas multisectoriales, fijar prioridades y monitorizar las intervenciones

Introduction: In our country trauma is the most frequent cause of death in children more than one year old, representing a high morbidity and an economic burden for the health system. Motor vehicle trauma (MVT) is one of the most frequent causes of severe injuries. Objective: To identify the causes, the kinematics and the injury topography and to analyze the impact of the epidemiological factors related to MVT of admitted patients to the "Ricardo Gutierrez" Children's Hospital. Modifiable risk factors were also analyzed. Methodology: Observational, prospective, analytical and predictive study. Forty seven (47) children between the ages of 0 and 18 years were included, all of them admitted with MVT injuries between April 1st 2015 and March 31st 2017, with follow up until discharge. A medical record was created with data from clinical history and interviews with parents. The enrolled inpatients were subdivided into three (3) groups: passengers, pedestrians and cyclists. Injury severity was assessed by the "Pediatric Trauma Index" (PTI) in two groups to identify risk factors for severe trauma (PTI ≤8) through a logistic regression model. Predictive variables: demographic characteristics in hospitalized children and their parents, socio-economic level and risk factors, event information, initial assistance and evolution of the clinical case. Injury topography was stratified in three (3) age groups. Results: Car hit was responsible for 68.1% of the events. Negligence was found in 36.2% of the causes. Central nervous system (CNS) was the most frequent topography: isolated in 42.6% and associated with other lesions in 57.5%. Identified risk factors: when PTI was >8 or critical, the risk probability to be admitted into intensive care units increased by 15.27 times. Conclusion: Car crash was the most frequent injury mechanism. Negligence and imprudence were 2/3 of the events causes. Children under three (3) years presented isolated CNS trauma (66%). PTI ≤8 was associated with high probability of intensive care requirement. Education, prevention programs and research are necessary in order to generate multisectoral proposals, to fix priorities, including monitoring and surveillance interventions

Pediatric trauma. Epidemiological study among patients admitted to Hospital de Niños "Ricardo Gutiérrez".

INTRODUCTION: In Argentina, trauma is the most common cause of death among children older than 1 year old, has a high morbidity rate, and results in large costs for the health system. OBJECTIVE: To identify causes of injuries in patients admitted to the hospital due to a trauma, and to analyze the relationship between epidemiological factors and severe trauma. POPULATION AND METHODS: Prospective study. Children and adolescents aged 0 to 18 years old admitted to the hospital due to unintentional trauma between April 2012 and March 2013 were included. They were divided into two groups based on severity according to the pediatric trauma score (8 or lower) to identify risk factors by means of a logistic regression model. PREDICTIVE OUTCOME MEASURES: patients' and parents' demographic characteristics, socioeconomic factors, event data, initial care, course, and risk factors. Patients were stratified into three age groups for the analysis of the type of injury and the anatomic location. RESULTS: Two hundred and thirty-seven patients were included. Traumatic brain injuries were predominant among children younger than 3 years old, while limb fractures were most common among children older than 3 years old. In the bivariate analysis, foreign parents, a state of poverty or destitution, an immediate preventable cause, dangerous heights, and an unsafe heating system were statistically significant outcome measures. Based on multiple regression, outcome measures included were foreign parents, living in a slum area, an immediate preventable cause, and an unsafe heating system. CONCLUSIONS: The main cause of trauma was related to falls from heights, and some of the studied socioeconomic factors were associated with a higher risk of trauma. This information may be useful to develop prevention measures.

Trauma en pediatría: Estudio epidemiológico en pacientes internados en el Hospital de Niños "Ricardo Gutiérrez" / Pediatric trauma: Epidemiological study among patients admitted to Hospital de Niños "Ricardo Gutiérrez"

Introducción. En Argentina, el trauma es la causa más frecuente de muerte en niños mayores de 1 año, con una elevada morbilidad y un alto costo para el sistema de salud. Objetivo. Identificar las causas de las lesiones en los pacientes internados por trauma y analizar la asociación entre los factores epidemiológicos y el trauma grave. Población y métodos. Estudio prospectivo. Se incluyeron los niños de 0-18 años internados por trauma no intencional entre abril de 2012 y marzo de 2013. Se dividieron en dos grupos según el índice de trauma pediátrico grave (8 o menor) para identificar factores de riesgo mediante un modelo de regresión logística. Variables predictivas: características demográficas del paciente y sus padres, factores socioeconómicos, datos del incidente, asistencia inicial, evolución y factores de riesgo. Se estratificaron en tres grupos etarios para el análisis de la topografía de la lesión. Resultados. Se incluyeron 237 pacientes. En menores de 3 años, predominó el traumatismo craneoencefálico y, en mayores de 3 años, las fracturas de miembros. En el análisis bivariado, padres extranjeros, indigencia o pobreza, causa inmediata prevenible, altura peligrosa y calefacción insegura resultaron estadísticamente significativos. Por regresión múltiple, quedaron incluidas las variables padres extranjeros, residencia en asentamiento, causa inmediata prevenible y calefacción insegura. Conclusiones. La principal causa de trauma fue la caída de altura y algunos de los factores socioeconómicos explorados se asociaron a mayor riesgo de trauma. Esto podría ser utilizado para elaborar medidas de prevención.

Introduction.In Argentina, trauma is the most common cause of death among children older than 1 year old, has a high morbidity rate, and results in large costs for the health system. Objective.To identify causes of injuries in patients admitted to the hospital due to a trauma, and to analyze the relationship between epidemiological factors and severe trauma. Population and Methods.Prospective study. Children and adolescents aged 0 to 18 years old admitted to the hospital due to unintentional trauma between April 2012 and March 2013 were included. They were divided into two groups based on severity according to the pediatric trauma score (8 or lower) to identify risk factors by means of a logistic regression model. Predictive outcome measures: patients' and parents' demographic characteristics, socioeconomic factors, event data, initial care, course, and risk factors. Patients were stratified into three age groups for the analysis of the type of injury and the anatomic location. Results.Two hundred and thirty-seven patients were included. Traumatic brain injuries were predominant among children younger than 3 years old, while limb fractures were most common among children older than 3 years old. In the bivariate analysis, foreign parents, a state of poverty or destitution, an immediate preventable cause, dangerous heights, and an unsafe heating system were statistically significant outcome measures. Based on multiple regression, outcome measures included were foreign parents, living in a slum area, an immediate preventable cause, and an unsafe heating system. Conclusions.The main cause of trauma was related to falls from heights, and some of the studied socioeconomic factors were associated with a higher risk of trauma. This information may be useful to develop prevention measures.

Trauma en pediatría: Estudio epidemiológico en pacientes internados en el Hospital de Niños "Ricardo Gutiérrez" / Pediatric trauma: Epidemiological study among patients admitted to Hospital de Niños "Ricardo Gutiérrez"

Introducción. En Argentina, el trauma es la causa más frecuente de muerte en niños mayores de 1 año, con una elevada morbilidad y un alto costo para el sistema de salud. Objetivo. Identificar las causas de las lesiones en los pacientes internados por trauma y analizar la asociación entre los factores epidemiológicos y el trauma grave. Población y métodos. Estudio prospectivo. Se incluyeron los niños de 0-18 años internados por trauma no intencional entre abril de 2012 y marzo de 2013. Se dividieron en dos grupos según el índice de trauma pediátrico grave (8 o menor) para identificar factores de riesgo mediante un modelo de regresión logística. Variables predictivas: características demográficas del paciente y sus padres, factores socioeconómicos, datos del incidente, asistencia inicial, evolución y factores de riesgo. Se estratificaron en tres grupos etarios para el análisis de la topografía de la lesión. Resultados. Se incluyeron 237 pacientes. En menores de 3 años, predominó el traumatismo craneoencefálico y, en mayores de 3 años, las fracturas de miembros. En el análisis bivariado, padres extranjeros, indigencia o pobreza, causa inmediata prevenible, altura peligrosa y calefacción insegura resultaron estadísticamente significativos. Por regresión múltiple, quedaron incluidas las variables padres extranjeros, residencia en asentamiento, causa inmediata prevenible y calefacción insegura. Conclusiones. La principal causa de trauma fue la caída de altura y algunos de los factores socioeconómicos explorados se asociaron a mayor riesgo de trauma. Esto podría ser utilizado para elaborar medidas de prevención.(AU)

Introduction.In Argentina, trauma is the most common cause of death among children older than 1 year old, has a high morbidity rate, and results in large costs for the health system. Objective.To identify causes of injuries in patients admitted to the hospital due to a trauma, and to analyze the relationship between epidemiological factors and severe trauma. Population and Methods.Prospective study. Children and adolescents aged 0 to 18 years old admitted to the hospital due to unintentional trauma between April 2012 and March 2013 were included. They were divided into two groups based on severity according to the pediatric trauma score (8 or lower) to identify risk factors by means of a logistic regression model. Predictive outcome measures: patients and parents demographic characteristics, socioeconomic factors, event data, initial care, course, and risk factors. Patients were stratified into three age groups for the analysis of the type of injury and the anatomic location. Results.Two hundred and thirty-seven patients were included. Traumatic brain injuries were predominant among children younger than 3 years old, while limb fractures were most common among children older than 3 years old. In the bivariate analysis, foreign parents, a state of poverty or destitution, an immediate preventable cause, dangerous heights, and an unsafe heating system were statistically significant outcome measures. Based on multiple regression, outcome measures included were foreign parents, living in a slum area, an immediate preventable cause, and an unsafe heating system. Conclusions.The main cause of trauma was related to falls from heights, and some of the studied socioeconomic factors were associated with a higher risk of trauma. This information may be useful to develop prevention measures.(AU)

Trauma en pediatría: Estudio epidemiológico en pacientes internados en el Hospital de Niños "Ricardo Gutiérrez" / Pediatric trauma: Epidemiological study among patients admitted to Hospital de Niños "Ricardo Gutiérrez"

Introducción. En Argentina, el trauma es la causa más frecuente de muerte en niños mayores de 1 año, con una elevada morbilidad y un alto costo para el sistema de salud. Objetivo. Identificar las causas de las lesiones en los pacientes internados por trauma y analizar la asociación entre los factores epidemiológicos y el trauma grave. Población y métodos. Estudio prospectivo. Se incluyeron los niños de 0-18 años internados por trauma no intencional entre abril de 2012 y marzo de 2013. Se dividieron en dos grupos según el índice de trauma pediátrico grave (8 o menor) para identificar factores de riesgo mediante un modelo de regresión logística. Variables predictivas: características demográficas del paciente y sus padres, factores socioeconómicos, datos del incidente, asistencia inicial, evolución y factores de riesgo. Se estratificaron en tres grupos etarios para el análisis de la topografía de la lesión. Resultados. Se incluyeron 237 pacientes. En menores de 3 años, predominó el traumatismo craneoencefálico y, en mayores de 3 años, las fracturas de miembros. En el análisis bivariado, padres extranjeros, indigencia o pobreza, causa inmediata prevenible, altura peligrosa y calefacción insegura resultaron estadísticamente significativos. Por regresión múltiple, quedaron incluidas las variables padres extranjeros, residencia en asentamiento, causa inmediata prevenible y calefacción insegura. Conclusiones. La principal causa de trauma fue la caída de altura y algunos de los factores socioeconómicos explorados se asociaron a mayor riesgo de trauma. Esto podría ser utilizado para elaborar medidas de prevención.(AU)

Introduction.In Argentina, trauma is the most common cause of death among children older than 1 year old, has a high morbidity rate, and results in large costs for the health system. Objective.To identify causes of injuries in patients admitted to the hospital due to a trauma, and to analyze the relationship between epidemiological factors and severe trauma. Population and Methods.Prospective study. Children and adolescents aged 0 to 18 years old admitted to the hospital due to unintentional trauma between April 2012 and March 2013 were included. They were divided into two groups based on severity according to the pediatric trauma score (8 or lower) to identify risk factors by means of a logistic regression model. Predictive outcome measures: patients and parents demographic characteristics, socioeconomic factors, event data, initial care, course, and risk factors. Patients were stratified into three age groups for the analysis of the type of injury and the anatomic location. Results.Two hundred and thirty-seven patients were included. Traumatic brain injuries were predominant among children younger than 3 years old, while limb fractures were most common among children older than 3 years old. In the bivariate analysis, foreign parents, a state of poverty or destitution, an immediate preventable cause, dangerous heights, and an unsafe heating system were statistically significant outcome measures. Based on multiple regression, outcome measures included were foreign parents, living in a slum area, an immediate preventable cause, and an unsafe heating system. Conclusions.The main cause of trauma was related to falls from heights, and some of the studied socioeconomic factors were associated with a higher risk of trauma. This information may be useful to develop prevention measures.(AU)

Pediatric trauma. Epidemiological study among patients admitted to Hospital de Niños "Ricardo Gutiérrez". / Pediatric trauma. Epidemiological study among patients admitted to Hospital de Niños "Ricardo Gutiérrez".

INTRODUCTION: In Argentina, trauma is the most common cause of death among children older than 1 year old, has a high morbidity rate, and results in large costs for the health system. OBJECTIVE: To identify causes of injuries in patients admitted to the hospital due to a trauma, and to analyze the relationship between epidemiological factors and severe trauma. POPULATION AND METHODS: Prospective study. Children and adolescents aged 0 to 18 years old admitted to the hospital due to unintentional trauma between April 2012 and March 2013 were included. They were divided into two groups based on severity according to the pediatric trauma score (8 or lower) to identify risk factors by means of a logistic regression model. PREDICTIVE OUTCOME MEASURES: patients and parents demographic characteristics, socioeconomic factors, event data, initial care, course, and risk factors. Patients were stratified into three age groups for the analysis of the type of injury and the anatomic location. RESULTS: Two hundred and thirty-seven patients were included. Traumatic brain injuries were predominant among children younger than 3 years old, while limb fractures were most common among children older than 3 years old. In the bivariate analysis, foreign parents, a state of poverty or destitution, an immediate preventable cause, dangerous heights, and an unsafe heating system were statistically significant outcome measures. Based on multiple regression, outcome measures included were foreign parents, living in a slum area, an immediate preventable cause, and an unsafe heating system. CONCLUSIONS: The main cause of trauma was related to falls from heights, and some of the studied socioeconomic factors were associated with a higher risk of trauma. This information may be useful to develop prevention measures.