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Rev Esp Quimioter 2019; 32(Suppl. 3):34-36

Safety and tolerability of ceftobiprole  

SANTIAGO GRAU

Ceftobiprole is a fifth generation cephalosporin with a series of characteristics differentiating it from other beta-lactams, including its antibacterial activity, mainly against methicillin-resistant Staphylococcus aureus, resistant Streptococcus pneumoniae and also Gram-negative microorganisms such as Pseudomonas aeruginosa. This antibiotic has been subjected to various clinical trials and the results of these have led to its approval in Spain for the treatment of nosocomial pneumonia, excluding that associated with mechanical ventilation, and community-acquired pneumonia. The results of various ceftobiprole clinical studies provide consistent information on efficacy and tolerability. Ceftobiprole as monotherapy has been shown to be non-inferior to comparator antibiotics in different settings. Information is available on its compatibility with other drugs in Y-site administration, important from the point of view of the intravenous treatment of patients who present venous access limitation. On the other hand, and in contrast to other cephalosporins, ceftobiprole presents a low risk of infection due to Clostridium difficile and, in comparison with ceftaroline, neutropenia has not been reported to present any significant issues.

Rev Esp Quimioter 2019; 32(Suppl. 3):34-36 [Full-text PDF]

 

 

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Rev Esp Quimioter 2019; 32(Suppl. 3):29-33

Possible clinical indications of ceftobiprole  

JOSÉ BARBERÁN

Ceftobiprole is a fifth-generation cephalosporin approved for the treatment of adult community-acquired pneumonia and non-ventilator associated hospital-acquired pneumonia. However, its microbiological and pharmacokinetic profile is very attractive as armamentarium for empirical monotherapy treatment in other infections too. Among these, the following scenarios could be considered complicated skin and soft tissue infections, moderate-severe diabetic foot infections without bone involvement, vascular-catheter-associated-bloodstream infections, and fever without apparent focus in the hospitalized patient without septic shock or profound immunosuppression.

Rev Esp Quimioter 2019; 32(Suppl. 3):29-33 [Full-text PDF]

 

 

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Rev Esp Quimioter 2019; 32(Suppl. 3):24-28

Ceftobripole: Experience in staphylococcal bacteremia  

ALEX SORIANO, LAURA MORATA

Ceftobiprole is a new cephalosporin with an extended spectrum activity against the majority of microorganisms isolated in bacteremia including methicillin-susceptible (MSSA) and -resistant S. aureus (MRSA). This antibiotic has demonstrated a potent activity against MRSA in animal models of endocarditis in monotherapy but particularly in combination with daptomycin, suggesting that this combination could be a future option to improve the outcome of staphylococcal endovascular infections. In addition, the extended-spectrum ceftobiprole activity, including coagulase-negative staphylococci, Enterococcus faecalis, Enterobacteriaceae and Pseudomonas aeruginosa represents an advantage for use as empirical therapy in bacteremia potentially caused by a broad spectrum of microorganisms, such as in catheter-related bacteremia.

Rev Esp Quimioter 2019; 32(Suppl. 3):24-28 [Full-text PDF]

 

 

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Rev Esp Quimioter 2019; 32(Suppl. 3):17-23

Ceftobiprole for the treatment of pneumonia  

CATIA CILLÓNIZ, CRISTINA DOMINEDÒ, CAROLINA GARCIA-VIDAL, ANTONI TORRES

Ceftobiprole is a fifth-generation cephalosporin with potent antimicrobial activity against Gram positive and Gram-negative bacteria. It has been approved in major European countries for the treatment of community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP). Ceftobiprole is currently in a phase 3 clinical program for registration in the U.S. In 2015, it was designated as an infectious disease product qualified for the treatment of lung and skin infections by the FDA. The efficacy of ceftobiprole in pneumonia has been demonstrated in two-phase III clinical trials conducted in patients with CAP and HAP. The recommended dose in the adult with pneumonia is 500 mg every 8 h infused in 2 h; in case of renal failure, the regimen of administration must be adjusted according to the patient’s renal function. It is not necessary to adjust the dose according to gender, age, body weight or liver failure. In case of hyperfiltration, an extension to 4 h infusion of the 500mg TID is required.

Rev Esp Quimioter 2019; 32(Suppl. 3):17-23 [Full-text PDF]

 

 

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Rev Esp Quimioter 2019; 32(Suppl. 3):11-16

Ceftobiprole: pharmacokinetics and PK/PD profile  

JOSÉ RAMÓN AZANZA PEREA, BELÉN SÁDABA DÍAZ DE RADA

Ceftobiprole shows many similar pharmacokinetic properties to other cephalosporins, except for not being orally bioactive, and that it is administered by IV infusion as the prodrug ceftobiprole medocaril, which is subsequently hydrolyzed in the blood into the active molecule. Distribution focus in extracellular fluid and active antibiotic concentration has been proven in different corporal tissues using dosing regimen of 500 mg intravenous infusion over 2 h every 8 h. Ceftobiprole is eliminated exclusively into the urine, thus the reason why dose adjustment is required for patients with moderate or severe renal impairment, or increased creatinine clearance. However, there is no need for dose adjustments related with other comorbidities and patients’ conditions such as age, body weight. Although considering distribution features, molecular weight and dose fraction, increase dosing regimen might be necessary in patients using renal replacement therapy. The half-life of ceftobiprole is more than 3 h, allowing to easily reach optimal PK/PD parameters with the infusion time of 2 h, using the usual dosing regimen.

Rev Esp Quimioter 2019; 32(Suppl. 3):11-16 [Full-text PDF]

 

 

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Rev Esp Quimioter 2019; 32(Suppl. 3):03-10

Mechanisms of action and antimicrobial activity of ceftobiprole  

MARÍA-ISABEL MOROSINI, MARÍA DÍEZ-AGUILAR, RAFAEL CANTÓN

Ceftobiprole, a novel last generation parenteral cephalosporin, has an extended spectrum of activity, notably against methicillin-resistant Staphylococcus aureus (MRSA), ampicillin-susceptible enterococci, penicillin-resistant pneumococci, Enterobacterales and susceptible Pseudomonas aeruginosa. It exerts an inhibitory action on essential peptidoglycan transpeptidases, interfering with cell wall synthesis. The inhibitory action of ceftobiprole through binding to abnormal PBPs like PBP2a in methicillin-resistant staphylococci and PBP2b and PBP2x in the case of ß-lactam-resistant pneumococci, ultimately leads to rapid bacterial cell death. In the case of Enterobacterales, ceftobiprole retains activity against narrow spectrum ß-lactamases but is hydrolysed by their extended-spectrum counterparts, overexpressed Amp C, and carbapenemases. It is also affected by certain efflux pumps from P. aeruginosa. For anaerobic bacteria, ceftobiprole is active against Gram-positive Clostridioides difficile and Peptococcus spp. and Gram-negative Fusobacterium nucleatum but not against Bacteroides group or other anaerobic Gram-negatives. In in vitro studies, a low propensity to select for resistant subpopulations has been demonstrated. Currently, ceftobiprole is approved for the treatment of community-acquired pneumonia and hospital-acquired pneumonia with the exception of ventilator-associated pneumonia. Ceftobiprole’s place in therapy appears to lie mainly in its combined activity against Gram-positive organisms, such as S. aureus and S. pneumoniae alongside that against Gram-negative organisms such as P. aeruginosa.

Rev Esp Quimioter 2019; 32(Suppl. 3):03-10 [Full-text PDF]

 

 

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Rev Esp Quimioter 2019; 32(4):400-409

Consensus document for sepsis code implementation and development in the Community of Madrid  

EDUARDO PALENCIA HERREJÓN, JUAN GONZÁLEZ DEL CASTILLO, FERNANDO RAMASCO RUEDA, FRANCISCO JAVIER CANDEL GONZÁLEZ, BEATRIZ SÁNCHEZ ARTOLA, ANDRÉS VON WERNITZ TELEKI, FEDERICO GORDO VIDAL, PATRICIA ROCES IGLESIAS, GUILLERMINA BEJARANO REDONDO, DIEGO ANÍBAL RODRÍGUEZ SERRANO, FRANCISCO JAVIER COBO REINOSO, ERVIGIO CORRAL TORRES, MILAGROS MARTÍ DE GRACIA, ANA RUIZ ÁLVAREZ Y EL GRUPO MULTIDISCIPLINAR CÓDIGO SEPSIS MADRID

The consensus paper for the implementation and development of the sepsis code, finished in April 2017 is presented here. It was adopted by the Regional Office of Health as a working document for the implementation of the sepsis code in the Community of Madrid, both in the hospital setting (acute, middle and long-stay hospitals) and in Primary Care and Out-of-Hospital Emergency Services. It is now published without changes with respect to the original version, having only added the most significant bibliographical references. The document is divided into four parts: introduction, initial detection and assessment, early therapy and organizational recommendations. In the second to fourth sections, 25 statements or proposals have been included, agreed upon by the authors after several face-to-face meetings and an extensive «online» discussion. The annex includes nine tables that are intended as a practical guide to the activation of the sepsis code. Both the content of the recommendations and their formal writing have been made taking into account their applicability in all areas to which they are directed, which may have very different structural and functional characteristics and features, so that we have deliberately avoided a greater degree of concretion: the objective is not that the sepsis code is organized and applied identically in all of them, but that the health resources work in a coordinated manner aligned in the same direction.

Rev Esp Quimioter 2019; 32(4):400-409 [Texto completo PDF]

 

 

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Rev Esp Quimioter 2019; 32(4):333-364

The situation of vaccines for the prevention of infections in adults: An opinion paper on the situation in Spain 

EMILIO BOUZA, JULIO ANCOCHEA-BERMÚDEZ, MAGDA CAMPINS, JOSÉ MARÍA EIRÓS-BOUZA, JESÚS FARGAS, AMÓS JOSÉ GARCÍA ROJAS, DIEGO GRACIA, ALIPIO GUTIÉRREZ SÁNCHEZ, AURORA LIMIA, JOSÉ ANTONIO LÓPEZ, MARÍA DEL CARMEN MAGRO, GLORIA MIRADA, PATRICIA MUÑOZ, EDUARDO OLIER, RAÚL ORTIZ DE LEJARAZU, LUIS URBIZTONDO, ESTEBAN PALOMO

The childhood immunization schedule is well known and generally well implemented in developed countries. For various reasons, the same is not true of vaccines aimed at preventing infections in adults, in which vaccination coverage is incomplete and generally very deficient. In order to assess the situation of adult vaccination in Spain, the Fundación de Ciencias de la Salud has brought together a series of experts in different fields, including doctors, nurses, representatives of patient associations, health managers and economists, health authorities and journalists to deal with this issue. The format was that of a round table in which a series of questions previously formulated by the coordinators were to be answered and debated. The document presented is not an exhaustive review of the topic, nor is it intended to make recommendations, but only to give a multidisciplinary opinion on topics that could be particularly debatable or controversial.  The paper reviews the main vaccine-preventable adult diseases, their clinical and economic impact, the possibilities of reducing them with vaccination programmes and the difficulties in carrying them out. The role of nursing, pharmacy services, patient associations and the health administration itself in changing the current situation was discussed. Prospects for new vaccines were discussed and we speculated on the future in this field. Finally, particularly relevant ethical aspects in decision-making regarding vaccination were discussed, which must be faced by both individuals and states. We have tried to summarize, at the end of the presentation of each question, the environment of opinion that was agreed with all the members of the table.

Rev Esp Quimioter 2019; 32(4):333-364 [Full-text PDF]

 

 

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Rev Esp Quimioter 2019; 32(4):375-378

Is it possible to extrapolate the rates of resistance of Escherichia coli from asymptomatic bacteriuria in pregnant women to those of E. coli in uncomplicated community-acquired UTI? 

ALEJANDRA ASENJO, MARTÍN C. GRADOS, JESÚS OTEO-IGLESIAS, JUAN-IGNACIO ALÓS

Objective. Treatment of uncomplicated urinary tract infections in primary care is generally empirical without requesting urine culture and based on biased resistance data collected from selected patients, most of them having risk factors for the isolation of resistant microorganisms. In order to overcome the lack of information on the real resistance rates in uncomplicated UTI, we compared antimicrobial phenotype and genotype of Escherichia coli isolated from pregnant women with asymptomatic bacteriuria (culture always performed) with those from women with uncomplicated acute cystitis (culture rarely performed) of different age groups.
Material and methods. Between September 2017 and March 2018, 103 urines were randomly collected from pregnant women aged between 16 and 47 with asymptomatic bacteriuria (AB) (n=42), not hospitalized women in the same age range with uncomplicated acute cystitis (UAC) (n=31) and women older than 47 not hospitalized with UAC (n=30). Bacteria identification was performed using mass spectrometry and the antibiogram by broth microdilution. Genetic typification was carried out by pulsed-field gel electrophoresis.
Results. There are no significant differences between the groups of patients in the antibiotic susceptibility. Likewise, as expected, a wide genetic diversity is observed among the strains of E. coli studied without significant differences between the three groups.
Conclusions. We propose a simple model that could provide better guidance for selection of empirical antimicrobial therapy for non-pregnant women with UAC than do generic hospital antibiogram data based on reliably extrapolating the susceptibility data of strains isolated from pregnant women with AB as representation of women with community-acquired UAC.

Rev Esp Quimioter 2019; 32(4):375-378 [Full-text PDF]

 

 

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Rev Esp Quimioter 2019; 32(4):317-326

Hospital admission and mortality causes of HIV patients in a third level hospital 

ROCÍO ASENSI-DIEZ, CRISTINA FERNÁNDEZ-CUERVA, JUAN JOSÉ ALCARAZ SÁNCHEZ, ISABEL MUÑOZ-CASTILLO

Introduction. The aim of this study is to describe the HIV population admitted to a tertiary level hospital and analyze hospital admission and mortality causes during hospitalization.
Material and methods. Observational, retrospective study carried out in a third level Hospital. Inclusion criteria: Patients ≥18 years with a prescription of ART and diagnosis of HIV known or discovered during admission. It was accepted hospital ward discharge diagnose as hospitalization causes. Clinical, analytical outcomes as well as causes of mortality were collected.
Results. Among 162 hospitalized HIV infected, 128 met the inclusion criteria, 8 of those were diagnosed as naive HIV patients. 79.7% were male; Age 50.29 ± 9.81 years. The main reasons for hospital admissions (38.3%) were certain infectious and parasitic diseases (ICD-10 Classification) and more specifically human immunodeficiency virus [HIV] disease represented 24,1% of whole hospitalizations. Mortality rates of ≥18 years HIV patients that were admitted to hospital during 2016-2017 were the 13.52%. The main causes of death were certain infectious and parasitic diseases followed by malignancies.
Conclusions. Our results emphasize the need of intensifying the HIV early diagnosis as well as Pneumocystis jirovecii primary prophylaxis. Insist on ART adherence from infectology follow-up appointment and pharmacy care consultations, educate clinics on ART treatment prescription during hospital admission as well as requesting viral and CD4 lymphocytes loads to every HIV admitted patients.

Rev Esp Quimioter 2019; 32(4):317-326 [Texto completo PDF]

 

 

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