Ensayos clínicos con medicamentos estériles. Análisis del Registro Español de ensayos clínicos / Clinical trials with steril preparations. Analysis of Spain clinical trial registry

Objetivo: Analizar el régimen jurídico para la preparación de productos estériles en el contexto de los ensayos clínicos.Método: Se ha completado una revisión bibliográfica de diferentes normas, guías e informes de organismos, así como de realizarse un análisis del Registro Español de Ensayos Clínicos (REec) para conocer la tendencia del tipo de ensayos clínicos que se realizan en España.Resultados: En la Unión Europea no existe una regulación específica en este asunto siendo responsabilidad de cada estado miembro legislar sobre ello. En el caso de España, existe una guía de buenas prácticas de preparación de medicamentos en servicios de farmacia hospitalaria.En cuanto al análisis del Registro Español de ensayos clínicos, se han obtenido datos que indican que aproximadamente el 50% de los estudios podrían requerir que estos fármacos en investigación sean preparados en condiciones de esterilidad, así como dentro de este grupo de estudios, el 79% son estudios de carácter internacional.Conclusiones: España tiene un marco normativo robusto en materia de preparación de medicamentos estériles tanto dentro de la práctica habitual como para fármacos en investigación clínica. Todos los profesionales involucrados en investigación clínica deben conocer esta regulación para seguir garantizando la posición de excelencia que tiene España en investigación clínica a nivel internacional. (AU)

Objective: To review the legal regime for sterile products preparation in the context of clinical trials.Method: A literature review of different rules, guideliness and reports from different organisms has been completed. Furthermore, an analysis of Spanish Clinical Trials Registry (REec) was performed in order to know the trend of what is the type of clinical trials that are being conducted in Spain.Results: at Europe Union there is not a specific regulation about this matter, being a member state responsibiliy to have a local law. In Spain, there is a guideline regarding Good Practices of preparation for drugs on Hospital Pharmacy Services. Spain Clinical Trials Registry analysis indicates that approximately 50% of studies could requiered that those study drugs to be pre-pared on sterile conditions, and on this group, 79% are international studies.Conclusions: Spain has solid regulations on sterile preparation drugs for routine practice and for clinical research drugs. All professionals involved in clinical research should be aware of these regulations in order to maintain Spain’s position of excellence in clinical research at the international level. (AU)

Ensayos clínicos con medicamentos estériles. Análisis del Registro Español de ensayos clínicos / Clinical trials with steril preparations. Analysis of Spain clinical trial registry

Objetivo: Analizar el régimen jurídico para la preparación de productos estériles en el contexto de los ensayos clínicos.Método: Se ha completado una revisión bibliográfica de diferentes normas, guías e informes de organismos, así como de realizarse un análisis del Registro Español de Ensayos Clínicos (REec) para conocer la tendencia del tipo de ensayos clínicos que se realizan en España.Resultados: En la Unión Europea no existe una regulación específica en este asunto siendo responsabilidad de cada estado miembro legislar sobre ello. En el caso de España, existe una guía de buenas prácticas de preparación de medicamentos en servicios de farmacia hospitalaria.En cuanto al análisis del Registro Español de ensayos clínicos, se han obtenido datos que indican que aproximadamente el 50% de los estudios podrían requerir que estos fármacos en investigación sean preparados en condiciones de esterilidad, así como dentro de este grupo de estudios, el 79% son estudios de carácter internacional.Conclusiones: España tiene un marco normativo robusto en materia de preparación de medicamentos estériles tanto dentro de la práctica habitual como para fármacos en investigación clínica. Todos los profesionales involucrados en investigación clínica deben conocer esta regulación para seguir garantizando la posición de excelencia que tiene España en investigación clínica a nivel internacional. (AU)

Objective: To review the legal regime for sterile products preparation in the context of clinical trials.Method: A literature review of different rules, guideliness and reports from different organisms has been completed. Furthermore, an analysis of Spanish Clinical Trials Registry (REec) was performed in order to know the trend of what is the type of clinical trials that are being conducted in Spain.Results: at Europe Union there is not a specific regulation about this matter, being a member state responsibiliy to have a local law. In Spain, there is a guideline regarding Good Practices of preparation for drugs on Hospital Pharmacy Services. Spain Clinical Trials Registry analysis indicates that approximately 50% of studies could requiered that those study drugs to be pre-pared on sterile conditions, and on this group, 79% are international studies.Conclusions: Spain has solid regulations on sterile preparation drugs for routine practice and for clinical research drugs. All professionals involved in clinical research should be aware of these regulations in order to maintain Spain’s position of excellence in clinical research at the international level. (AU)

High delayed mortality after the first episode of Clostridium difficile infection.

Clostridium difficile infection (CDI) is characterized by a high delayed and unrelated mortality. Predicting delayed mortality in CDI patients could allow the implementation of interventions that could reduce these events. A prospective multicentric study was carried out to investigate prognostic factors associated with mortality. It was based on a cohort (July 2015 to February 2016) of 295 patients presenting with CDI. Logistic regression was used and the model was calibrated using the Hosmer-Lemeshow test. The mortality rate at 75 days in our series was 18%. Age (>65 years), comorbidity (defined by heart failure, diabetes mellitus with any organ lesion, renal failure, active neoplasia or immunosuppression) and fecal incontinence at clinical presentation were associated with delayed (75-day) mortality. When present, each of the aforementioned variables added one point to the score. Mortalities with 0, 1, 2 and 3 points were 0%, 9.4%, 18.5% and 38.2%, respectively. The area under the ROC curve was 0.743, and the Hosmer-Lemeshow goodness-of-fit test p value was 0.875. Therefore, the prediction of high delayed mortality in CDI patients by our scoring system could promote measures for increasing survival in suitable cases.

Risk Factors for Clostridium Difficile Diarrhea in Patients With Solid Organ Transplantation.

BACKGROUND: There is limited knowledge about specific risk factors for Clostridium difficile infection (CDI). METHOD: A retrospective study comparing cases of CDI in solid organ transplant (SOT) recipients with controls (SOT recipients who did not present CDI). RESULTS: Thirty patients with SOT from 1340 transplantation recipients had at least 1 episode of CDI (2.23%). The accumulated incidence was 3.06% in liver transplantation, 2.78% in lung transplantation, 2.36% in kidney transplantation, and 0.33% in heart transplantation. Seven (23%) cases occurred during the first 2 months. Fifteen (50%) cases were community acquired. Colonoscopy was performed in 6 (20%) cases, but pseudomembranes were observed in only 1 (16%) case. Independent variables found to be related to CDI were previous treatment with proton pump inhibitors (PPIs; odds ratio [OR] 5.5; 95% confidence interval [CI] 1.2-32.0), immunosuppressive regimen including mycophenolate (OR 5.2; 95%CI 1.1-18), hospitalization during the previous 3 months (OR 5.1; 95%CI 1.1-17), and antibiotic treatment during the previous month (OR 6.7; 95%CI 1.4-23). Five (16.7%) patients did not respond to the initial treatment. Recurrences were noted in 6 (20%) patients. CONCLUSIONS: Liver transplant recipients presented the highest incidence. Risk factors for CDI were previous treatment with PPIs, immunosuppressive regimen containing mycophenolate, prior hospitalization, and prior antibiotic treatment.

Predictores de mortalidad en pacientes con hemoptisis en un servicio de emergencia / Predictors of mortality in patients with hemoptysis in the emergency room

Introducción. La hemoptisis es una de las manifestaciones más alarmantes de las enfermedades broncopulmonares y representa el 7% de los ingresos hospitalarios a los servicios de medicina Interna. La hemoptisis severa está relacionada a cifras altas de mortalidad alrededor del 40%. Existen múltiples factores que cuando coexisten con hemoptisis alteran su evolución y pronóstico. No solo la severidad de la hemoptisis determina el riesgo de muerte, sino la presencia de comorbilidades, especialmente pulmonares que afectan la reserva funcional del paciente. Objetivos. Determinar la mortalidad y los factores que incrementan la mortalidad en pacientes con hemoptisis que son admitidos por un servicio de emergencia. Diseño. Estudio analítico. Institución. Servicio de emergencia, Hospital Nacional Dos de Mayo, Lima, Perú. Participantes. Pacientes con diagnóstico de hemoptisis. Métodos. Se revisaron 10S historias clínicas de pacientes que fueron hospitalizados por emergencia con diagnóstico de hemoptisis en un lapso de 2 años. Se recolectaron las variables edad, sexo, procedencia, presencia de comorbilidades, reserva funcional respiratoria cualitativa, entre otros. Los resultados se expresaron en distribución de frecuencias absolutas y relativas, medias (±.1 DE); los factores relacionados a incremento de mortalidad se les determinó mediante el estimado del riesgo relativo (RR). Para la comparación de proporciones se utilizó la prueba chi2. Para determinar las variables asociadas a mortalidad se usó el modelo de regresión logística múltiple. Principales medidas de resultados. Factores asociados a incremento de mortalidad. Resultados. Los factores asociados a incremento de mortalidad fueron la presencia de caverna mayor de 1 cm de diámetro, de localización hiliar, y el antecedente de readmisiones por hemoptisis. Así mismo, la presencia de fibrosis pulmonar que comprometía más de 50% del parénquima pulmonar bilateral fue importante predictor de mortalidad. Conclusiones. La reserva funcional pulmonar fue el determinante principal relacionado a mortalidad en pacientes con hemoptisis que fueron hospitalizados por emergencia.

Introduction. Hemoptysis is one of the most alarming manifestations of bronchopulmonary diseases and represents 7% of hospital admissions to Internal Medicine services. Severe hemoptysis is related to high mortality in about 40%. Multiple factors that coexist with hemoptysis alter its evolution and prognosis. Not only the severity of the hemoptysis determines the risk of death, but also the presence of comorbid conditions, especially pulmonary pathologies affecting the patient's functional reserve. Objectives. To determine the mortality and factors that increase mortality in patients with hemoptysis admitted by the Emergency Room. Design. Analytical study. Setting. Hospital Nacional Dos de Mayo, Lima, Peru. Participants. Patients with hemoptysis. Methods. We reviewed 10S clinical histories of patients who were hospitalized as an emergency with the diagnosis of hemoptysis during a time lapse of 2 years. Variables such as age, sex, origin, presence of comorbidities, were collected. Results were expressed in absolute and relative frequency, means (+ DE); the factors associated with increased mortality were determined by relative risk (RR). Chi2 test was used to compare proportions. Multiple logistic regression models were used to determine the variables associated with mortality. Main outcome measures: Factors associated with increased mortality. Results. Factors associated with increased mortality were the presence of a cavity larger than 1 cm of diameter, hiliar location, and a previous history of readmissions for hemoptysis. The presence of pulmonary fibrosis involving more than 50% of the bilaterallung parenchyma was the main predictor of mortality. Conclusions. Pulmonary functional reserve was the main mortality-related determinant in patients with hemoptysis who were hospitalized in the Emergency Room.