Ceftazidime-avibactam: effectiveness and safety in the clinical practice. A third hospital level experience / Ceftazidima-avibactam: efectividad y seguridad en práctica clínica habitual. Experiencia de un hospital de tercer nivel

Objectives: Ceftazidime/avibactam (CZA) is a third generation cephalosporin and the first non-beta-lactam beta-lactamase inhibitor combination. The main outcome was to assess the effectiveness and safety of CZA in the clinical practice.Methods: It was a retrospective observational study. The inclusion criteria were age >18 years and receipt of >24 hours of CZA between January 2016 and October 2018. Variables studied included demographic, clinical, and treatment.Results: 63 inpatients in treatment with CZA were included, 39 (61.9 %) were male and the mean (SD) age was 64.3 (15.8) years. Thirty-eight (60.3%) patients presented bacteremia and 28 (44.4%) were admitted in Intensive Care Unit (ICU). Klebsiella pneumoniae were isolated in 43 (68.3) patients, and OXA-48 carbapenemase in 51 (81.0%). Concomitant antibiotic was used in 40 (63.5%) patients. Mortality at 14 and 30 days were 6 (9.5%) and 4 (6.3%) patients, respectively.Thirty-five (55.6%) patients reached microbiological cure and 47 (74.6%) clinical cure. Infection recurrence evaluated at 90 days was achieved in 23 (36.5%) patients. ICU admission and bacteremia showed decreased in clinical cure (p=0.023 and p=0.01, respectively). Only ICU admission had a diminution in microbiological cure (p=0.035) and bacteremia a higher recurrence evaluated at 90 days (p=0.003). Only 3 (4.8%) patients interrupted treatment because of the adverse events.Conclusions: ICU admission had demonstrated a microbiological and clinical cure decreasing. Recurrence evaluated a 90 days was statically significant higher in patients with bacteremia. CZA was a security antibiotic, with a very low incidence of treatment interruptions. (AU)

Objetivo: Ceftazidima/avibactam (CZA) es una cefalosporina de tercera generación y el primer inhibidor de beta-lactamasas no beta-lactámico. El objetivo principal fue evaluar su efectividad y seguridad en la práctica clínica.Métodos: Se realizó un estudio observacional retrospectivo. Los criterios de inclusión fueron: edad >18 años y administración de >24 horas de CZA entre enero de 2016 y octubre de 2018. Las variables estudiadas incluyeron demograficas, clínicas y de tratamiento.Resultados: Se incluyeron 63 pacientes con CZA, 39 (61,9 %) fueron hombres, media (SD) de edad de 64,3 (15,8) años. 38 (60,3%) pacientes presentaron bacteriemia y 28 (44,4%) fueron ingresados en la Unidad de Cuidados Intensivos (UCI). Klebsiella pneumoniae se aisló en 43 (68,3) pacientes y OXA-48 carbapenemasa en 51 (81,0%). 40 (63,5%) pacientes recibieron antibiótico concomitante. La mortalidad a los 14 y 30 días fue de 6 (9,5%) y 4 (6,3%), respectivamente.Treinta y cinco (55,6%) alcanzaron curación microbiológica y 47 (74,6%) curación clínica. Recurrencia de la infección a los 90 días sucedió en 23 (36,5%). El ingreso en UCI y la bacteriemia demostraron una disminución de la curación clínica (p-0,023 y p-0,01, respectivamente). El ingreso en UCI tuvo una disminución en curación microbiológica (p-0,035) y la bacteriemia en una mayor recurrencia a los 90 días (p-0,003). 3 (4,8%) interrumpieron el tratamiento por toxicidad.Conclusiones: El ingreso en UCI se relacionó con disminución de curación microbiológica y clínica. La recurrencia a los 90 días fue mayor en pacientes con bacteriemia. CZA presenta una incidencia baja de interrupciones del tratamiento. (AU)

[Comparison of two formulae for the calculation of glomerular filtration in the dosage of zoledronic acid]. / Comparación de dos fórmulas de cálculo de filtrado glomerular en la dosificación del ácido zoledrónico.

OBJECTIVE: To validate the use of a formula that does not require the patient's weight (Levey formula) for calculating creatinine clearance in the adjustment of the dosage of zoledronic acid. METHOD: Prospective observational study in which zoledronic acid prescriptions in the Oncology and Haematology departments were recorded over the course of 8 months. The adjustment of the dose of zoledronic acid was carried out in accordance with creatinine clearance obtained using two different equations; the Cockcroft-Gault equation which is based on medical records, and the Levey formula which does not require the patient's weight for the calculation. The results of zoledronic acid dosage from both equations were compared using the SPSS statistics programme, via the comparison of the two measurements using the t Student-Fisher (T-test.) RESULTS: The T-Test provided a t-test value of t = 3,366, with 112 degrees of freedom and a degree of bilateral importance of p = 0.001. The difference between both measurements was d = 0.051 +/- 0.162) and the confidence interval was 95 %, 0.082 to 0.021. From the data obtained in the T-Test, the degree of bilateral importance (p = 0.001 < 0.05) indicated that the results of the test were statistically significant. CONCLUSIONS: The difference between the dosages obtained when comparing both methods of glomerular filtration is statistically significant, although not clinically relevant, therefore the MDRD-4 formula (Levey) could be used if the patient's weight is not available.

Comparación de dos fórmulas de cálculo de filtrado glomerular en la dosificación del ácido zoledrónico / Comparison of two formulae for the calculation of glomerular fi ltration in the dosage of zoledronic acid

Objetivo: Validar la utilización de una fórmula que no requiera del peso del paciente (fórmula de Levey) para el cálculo del aclaramiento de creatinina en el ajuste de la dosificación del ácido zoledrónico. Método: Estudio observacional prospectivo en el que se recogen durante un período de 8 meses las prescripciones de ácido zoledrónico realizadas en los servicios de Oncología y Hematología. Se realiza el ajuste de la dosis de ácido zoledrónico de acuerdo con el aclaramiento de creatinina obtenido mediante 2 ecuaciones diferentes: a) la fórmula de Cockcroft-Gault, que es la propuesta en la ficha técnica del medicamento, y b) la fórmula de Levey, que no requiere del peso del paciente para su cálculo. Se comparan los resultados de dosificación de ácido zoledrónico de ambas ecuaciones con el programa estadístico SPSS, mediante la prueba de comparación de 2 medias calculando la t de Student-Fisher (T-test). Resultados: La prueba t proporcionó un valor t = ¿3,366, con 112 grados de libertad y un grado de significación bilateral p = 0,001. La diferencia entre ambas medias ± desviación estándar fue de ¿0,051 ± 0,162, y el intervalo de confianza del 95 %, ¿0,082 a ¿0,021. A partir de los datos obtenidos en la prueba estadística T-test, el grado de significación bilateral p = 0,001 < 0,05 indicó que el resultado de la prueba era estadísticamente significativo. Conclusiones: La diferencia de dosis obtenida al comparar ambos métodos de cálculo del filtrado glomerular es estadísticamente significativa, aunque sin relevancia clínica, con lo que se podría utilizar la fórmula de la Modification of Diet in Renal Disease 4 (Levey), si no disponemos del peso del paciente (AU)

Objective: To validate the use of a formula that does not require the patient’s weight (Levey formula) for calculating creatinine clearance in the adjustment of the dosage of zoledronic acid.Method: Prospective observational study in which zoledronic acid prescriptions in the Oncology and Haematology departments were recorded over the course of 8 months. The adjustment of the dose of zoledronic acid was carried out in accordance with creatinine clearance obtained using two different equations; the Cockcroft-Gault equation which is based on medical records, and the Levey formula which does not require the patient’s weight for the calculation. The results of zoledronic acid dosage from both equations were compared using the SPSS statistics programme, via the comparison of the two measurements using the t Student-Fisher (T-test.)Results: The T-Test provided a t-test value of t = —3,366, with 112 degrees of freedom and a degree of bilateral importance of p = 0.001. The difference between both measurements was d = —0.051 ± 0.162) and the confidence interval was 95 %, —0.082 to —0.021. From the data obtained in the T-Test, the degree of bilateral importance (p = 0.001 < 0.05) indicated that the results of the test were statistically significant. Conclusions: The difference between the dosages obtained when comparing both methods of glomerular filtration is statistically significant, although not clinically relevant, therefore the MDRD-4 formula (Levey) could be used if the patient’s weight is not available (AU)