[Temporal evolution of antiretroviral therapy (2017-2021): analysis of treatment change and its economic impact]. / Evolución temporal de la terapia antirretroviral (2017-2021): análisis de la modificación del tratamiento y su impacto económico.

OBJECTIVE: To analyze the modifications of antiretroviral therapy (ART) and their economic impact on daily clinical practice. METHODS: Observational, retrospective study of patients who started ART between 01/2017-12/2021 (follow-up until 12/2022). Variables collected: prescribed ART, duration, the reason for the change, and treatment costs. RESULTS: A total of 280 patients initiated ART therapy. The median durability of 1st line was: 19.9 months in 2017 (95%CI 13.9-25.9), 12.2 months in 2018 (95%CI 4.7-19.7), 27.4 months in 2019 (95%CI 6.8-48.1) and the median was not reached for the years 2020 and 2021 (p<0.001). Triple therapy with protease inhibitors was changed in 63.8% (81/127) of cases, followed by integrase inhibitors 52.1% (159/305), while dual therapy (DTG/3TC) only in 8.3% (7/84). The main cause of discontinuation was simplification/optimization 47.5% (124/261), followed by adverse effects 21.8% (57/261), with 2017 being the only year where simplification/optimization was at the same level as adverse effects. The economic impact of ART changes resulted in an average cost reduction of 34.0€ [-391.4 to +431.4] per month per patient. The year 2019 stands out as the only year where these changes were associated with an increase in mean additional cost (23.4€ [-358.3 to +431.4]). CONCLUSIONS: Optimization/simplification accounts for almost half of the reasons for TAR change, with an economic impact that, despite the inflection point of 2019, each year manages to exceed the previous one, achieving a progressive cost reduction maintained over time.

[Adequacy of the consumption of antipseudomonal antibiotics after changes in the 2019 EUCAST criteria]. / Adecuación de la prescripción de antibióticos antipseudomónicos tras los cambios en los criterios EUCAST 2019.

OBJECTIVE: In 2019, the European Committee for the Study of Antibiotic Susceptibility modified the categories of antibiotic susceptibility tests to include the term "susceptible with increased exposure". Following the dissemination of local protocols reflecting these modifications, the aim of our study was to analyse whether prescribers have adapted to them and the clinical impact in cases of inadequacy. METHODS: Observational and retrospective study of patients with infection who received antipseudomonal antibiotics from January to October 2021 in a tertiary hospital. RESULTS: Non-adherence to the guideline recommendations was 57.6% in the ward and 40.4% in the ICU (p<0.05). In both the ward and ICU, the group with the most prescriptions not by the guideline recommendations were aminoglycosides (92.9% and 64.9% respectively) for using suboptimal doses, followed by carbapenems (89.1% and 53.7% respectively) for not administering an extended infusion. On the ward, the mortality rate during admission or at 30 days in the inadequate therapy group was 23.3% vs 11.5% in those who received adequate treatment (OR: 2.34; 95% CI 1.14-4.82); in ICU there were no statistically significant differences. CONCLUSIONS: The results show the need to implement measures to ensure better dissemination and knowledge of key concepts in antibiotic management, to ensure increased exposures, and to be able to provide better infection coverage, as well as to avoid amplifying resistant strains.

Trombocitopenia asociada a ceftarolina en combinación con daptomicina: a propósito de dos casos / Thrombocytopenia associated with ceftaroline in combination with daptomycin: report of two cases

Introducción: La trombocitopenia inducida por fármacos es un efecto adverso cuya incidencia es desconocida, pero que puede ser potencialmente severo. Pacientes y métodos: Se presentan los casos de dos pacientes con trombocitopenia asociada a ceftarolina y/o daptomicina utilizados en asociación en el tratamiento de endocarditis infecciosa por Staphylococcus aureus meticilin-resistente (SARM). Resultados: En los dos casos descritos se observó un descenso en el recuento de plaquetas durante el tratamiento combinado, continuando el efecto pese a la reducción de dosis y asociándose a ceftarolina por la secuencia temporal fármaco/efecto.Ambos casos fueron notificados al Servicio de Farmacovigilancia. La evaluación de causalidad de ceftarolina mediante el algoritmo de Karch Lasagna modificado por Naranjo et al. resultó como posible en primer caso y probable en el segundo.Conclusiones: Ante los dos casos descritos y otros recogidos en la revisión bibliográfica sobre el riesgo de trombocitopenia asociada a ceftarolina, se plantea la necesidad de realizar controles hematológicos, especialmente en pacientes con tratamientos prolongados y/o con dosis elevadas. Son necesarios estudios postautorización para evaluar la incidencia de efectos adversos poco frecuentes. (AU)

Introduction: Drug-induced thrombocytopenia is an adverse effect whose incidence is unknown, but which can be potentially severe. Patients and methods: The cases of two patients with thrombocytopenia associated with ceftaroline and/or daptomycin used in association in the treatment of infective endocarditis due to methicillin-resistant Staphylococcus aureus (MRSA) are presented. Results: In the two cases described, a decrease in the platelet count is shown during the combined treatment, continuing the effect despite the dose reduction and being associated with ceftaroline due to the drug/effect temporal sequence. Both cases were notified to the Pharmacovigilance Service. The causality assessment of ceftaroline using the Karch Lasagna algorithm modified by Naranjo et al. was possible in the first case and probable in the second. Conclusions: Given the two cases described and others collected in the literature review on the risk of thrombocytopenia associated with ceftaroline, it is necessary to carry out haematological controls, especially in patients with prolonged treatments and/or with high doses. Post-authorization studies are necessary to assess the incidence of rare adverse effects. (AU)

Reactivación de citomegalovirus en pacientes críticos con infección por COVID-19 / Cytomegalovirus reactivation in critically ill patients with COVID-19 infection

Introducción: Existe bastante evidencia sobre la reactivación del citomegalovirus (CMV) en pacientes críticos y se ha planteado que pueda ser una de las coinfecciones que puedan aumentar la morbimortalidad en pacientes con infección severa por COVID-19. Por ello, se plantea un estudio para analizar las características de los pacientes COVID-19 que recibieron tratamiento anticitomegalovirus en la Unidad de Ciudados Intensivos (UCI). Material y métodos: Estudio multidisciplinar, observacional, retrospectivo, unicéntrico que incluyó todos los pacientes con COVID-19 en UCI que fueron tratados con ganciclovir o foscarnet entre marzo-2020 y abril-2021 en un hospital terciario. Variables: demográficas, relacionadas con el tratamiento para CMV, tratamiento recibido para COVID-19, estancia hospitalaria, mortalidad intrahospitalaria y al alta. Resultados: En el período de estudio, 26 pacientes críticos con COVID-19, recibieron algún tratamiento anticitomegalovirus (69,2% hombres, mediana de edad 64 años). En 15 (57,7%) se confirmó la reactivación microbiológicamente, y estos pacientes tuvieron estancias más prolongadas que los tratados sin confirmación. La mortalidad en el grupo tratado fue del 84,6% (80,0% en los que se confirmó reactivación), frente al 43,0% de mortalidad en el global de 300 pacientes COVID-19 que requirieron UCI en ese período. La tasa de infección demostrada de CMV fue del 5,0%. Conclusiones: Aunque existen publicaciones que sugieren un mayor riesgo de reactivación de CMV en pacientes COVID-19, la incidencia en nuestro estudio fue inferior a la descrita en pacientes críticos COVID. Hay que destacar la elevada mortalidad en los pacientes del estudio frente al global de pacientes atendidos en UCI por COVID-19. (AU)

Introduction: There is considerable evidence on the reactivation of cytomegalovirus (CMV) in critically ill patients and it has been suggested that it may be one of the co-infections that may increase morbidity and mortality in patients with severe COVID-19 infection. Therefore, a study was proposed to analyze the characteristics of COVID-19 patients who received anti-cytomegalovirus treatment in the Intensive Care Unit (ICU). Material and methods: Multidisciplinary, observational, retrospective, single-center study that included all patients with COVID-19 in ICU who were treated with ganciclovir or foscarnet between March-2020 and April-2021 in a tertiary hospital. Variables: demographic, related to treatment for CMV, treatment received for COVID-19, hospital stay, in-hospital mortality and at discharge. Results: In the study period, 26 critically ill patients with COVID-19 received some anti-cytomegalovirus treatment (69.2% men, median age 64 years). In 15 (57.7%) reactivation was confirmed microbiologically, and these patients had longer stays than those treated without confirmation. Mortality in the treated group was 84.6% (80.0% in those with confirmed reactivation), compared to 43% mortality in the overall of 300 COVID-19 patients who required ICU in that period. The demonstrated infection rate of CMV was 5.0%. Conclusions: Although there are publications that suggest a higher risk of CMV reactivation in COVID-19 patients, the incidence in our study was lower than that described in critical COVID patients. It should be noted the high mortality in the study patients compared to the overall number of patients seen in the ICU for COVID-19. (AU)

[Utilization study in real clinical practice of ceftolozane/tazobactam vs aminoglycosides and/or colistin in the treatment of multirresistant or extremely resistant Pseudomonas aeruginosa]. / Estudio de utilización en práctica clínica real de ceftolozano/tazobactam frente a aminoglucósidos y/o colistina en el tratamiento de Pseudomonas aeruginosa.

OBJECTIVE: Comparative "real life" data on the effectiveness and safety of ceftolozane/tazobactam (C/T) versus other regimens (aminoglycosides/colistin/combination), in the treatment of multi-resistant (MDR) and extremely resistant (XDR) Pseudomonas aeruginosa (PA), are needed to establish positions. METHODS: Observational, retrospective study of patients with microbiological confirmation of MDR and XDR PA from July 2016 up to December 2018 in a tertiary hospital. Variables: age, sex, comorbidities, risk factors for multidrug resistance, variables related to infection, source of infection, microorganism and type of sample, antibiotic treatment, clinical cure, microbiological cure, recurrence, mortality on admission and 30 days post-discharge. Patients were classified according to received antibiotic treatment, C/T or aminoglycosides/colistin/combination. RESULTS: A total of 405 patients with PA MDR and XDR infection (73.1% men, mean age 63 ± 15 years) were studied. An 87.1% of PA XDR and a 12.9% MDR were observed. All patients received C/T as targeted therapy and in the aminoglycosides/colistin/combination group were 73.5%. Patients in the C/T group present worse prognostic factors: septic shock (30.0%) and catheterization (90.0%) (p<0.05). There were not statistically significant differences in microbiological cure (p=0.412), recurrence (p=0.880) and clinical cure (p=0.566). There were not statistically significant differences in mortality at admission (p=0.352) or at 30 days after discharge (p=0.231). A 17.2% of the patients with aminoglycosides/colistin/combination had acute kidney injury according to RIFLE criteria and 4.3% with C/T. CONCLUSIONS: The data obtained suggest that there have been no differences in effectiveness (clinical or microbiological cure) in favour of C/T, although, in the period studied, it was used in most cases in multitreated patients with a worse prognosis. Randomized and prospective studies would be needed to establish an adequate positioning.

[Assessment of outcomes of implementing the Sepsis Code in the emergency department of a tertiary hospital]. / Evaluación de los resultados de la implantación del Código Sepsis en el servicio de urgencias de un hospital terciario.

INTRODUCTION: A Sepsis Code (CS) is a comprehensive multidisciplinary system which has the aim of optimising the identification and intervention times of patients with sepsis, as well as improving their monitoring and treatment adjustments in order to reduce their mortality. OBJECTIVES: To present the outcomes of the first year of introducing the CS in the emergency department of a tertiary hospital. MATERIAL AND METHODS: A single-centre retrospective descriptive observational study was conducted on all patients in whom the CS was activated in the emergency department of a tertiary hospital during the first year of implementation. The variables included: demographics, CS activation, comorbidities, focus of infection, microbiology, antibiotic treatment, and mortality. RESULTS: CS was activated in 555 patients, of which 302 (54.4%) had a definitive diagnosis of sepsis or septic shock on discharge from the emergency department. The degree of completion of the protocol variables was variable (41.8-95%).The large majority (86.1%) of the patients received antibiotics in the first hour, and in 76.2% blood cultures were collected prior to the antibiotic. Of the blood cultures performed, 13.3% of the isolated germs were multi-resistant and the level of contamination of blood cultures was 9.1%. All patients received empirical treatment and recommendations were followed in patients with septic shock in 28.3%. During follow-up, 64.4% the antibiotic treatment was targeted, and 39.5% received sequential therapy. In-hospital mortality was 32.2%. CONCLUSIONS: Areas of improvement in the completion of the variables, contamination of blood cultures, and empirical treatment received were detected, with the strong points being the early administration of the antibiotic and the collection of blood cultures.