Cefepime/sulbactam is a combined antibiotic consisting of the 4 th generation cephalosporin cefepime and the beta-lactamase inhibitor sulbactam in 1:1 ratio. Cefepime/sulbactam antibiotic was developed in Russia in 2006, it had passed preclinical and clinical studies, was approved for medical use, and has been produced in Russia since 2019. Cefepime has a wide spectrum of antimicrobial activity against gram-positive and gram-negative microorganisms, sulbactam adds two clinically important pathogens to the antimicrobial spectrum of cefepime — Acinetobacter baumannii and Bacteroides fragilis. In addition, sulbactam protects cefepime from hydrolysis by class A broad- and extended-spectrum beta-lactamases, and cefepime itself is stable against class C chromosomal beta-lactamases and partially stable to OXA-type class D carbapenemases. In vitro studies have shown that most clinical strains of ESBL-producing Klebsiella pneumoniae, Escherichia coli, Proteus spp. are sensitive to cefepime/sulbactam, as well as some strains of K.pneumoniae and A.baumannii that are resistant to carbapenems as a result of the production of class D carbapenemases. The efficacy and safety of cefepime/sulbactam have been determined in three clinical studies. Clinical and bacteriological efficacy of the drug was 97.9% and 97.6% in patients with acute community-acquired pyelonephritis. In the MAXI-19 multicenter study, the clinical efficacy of cefepime/sulbactam in patients with intra-abdominal infections, nosocomial pneumonia, and ventilator-associated pneumonia was 78.4, 90.3, and 80.7%, respectively. A comparative study examined the efficacy of cefepime/sulbactam and carbapenems in severe nosocomial infections (84% of patients had sepsis or septic shock). Clinical efficacy of cefepime/sulbactam and carbapenems was high and did not significantly differ (71% vs. 62%), as well as the bacteriological efficacy — 87% vs. 73%, while typical hospital pathogens characterized by MDR or XDR were identified in the majority of patients (most often — K.pneumoniae, A.baumannii, E.coli). During treatment with carbapenems, carbapenem-resistant bacteria were detected significantly more often (74.5%, most often A.baumannii — 44.7%, K.pneumoniae — 38.3%), compared to cefepime/sulbactam (20.0%, P.aeruginosa and K.pneumoniae, both at 15.5%), P=0.0001. The risk of superinfection was also significantly higher with carbapenems than with cefepime/sulbactam (53.3% vs. 22.2%, P=0.001). For severe infections, cefepime/sulbactam was administered at a dose of 4 g (2 g + 2 g) every 12 hours or 2 g (1 g + 1 g) every 8 hours. Currently, cefepime/sulbactam should be considered as a reliable option for the treatment of severe infections in the hospital as a carbapenem-replacement strategy to reduce the risks of selection of carbapenem-resistant gram-negative bacteria.
Objective. assessment of the evolution of the microbiological landscape of the hospital for the period of operation in 2020 into a pandemic of a new coronavirus infection in various departments, including intensive care units; change depending on the results of antibacterial therapy regimens. Materials and Methods. In a retrospective study, conducted from June to December 2020, in a multidisciplinary hospital working with COVID-19 infection, the resistance of isolated strains of microorganisms was analyzed in patients of different age groups. Resistance was assessed with test points in June and November 2020; depending on this, proposals were made to correct the internal (local) protocols of antimicrobial therapy. Results. The need for frequent and regular microbiological monitoring was confirmed. Further, we understood that the territories of the main and temporary hospital of the City Clinical Hospital No. 40 are heterogeneous and there are obvious differences both in structure and in the level of sensitivity. “In practice, these are two different hospitals”. Within the territories, the branches also differ from each other. When analyzing resistance in ICUs, it was revealed that within each hospital in each department, albeit similar in structure and profile of patients, there is a different level of resistance of strains. Conclusions. The structure of sensitivity generally corresponds to the world data, but for some pathogens it differs significantly. Microbiological monitoring should be carried out not only inside the hospital, but also inside the department. The increase in consumption of carbapenems and protected cephalosporins requires a reassessment of the practice of using AMP in any covid hospital, due to the impact on the epidemic situation both in the ICUs and in the hospital.
The aim of the study was to evaluate the effectiveness of cefepime/sulbactam in patients with intra-abdominal infection, nosocomial pneumonia (NP) or ventilator-associated pneumonia (VAP) in actual clinical practice. Material and methods. The study was conducted in 14 Russian Clinics from October 2019 to March 2020. Study design: an open-label, prospective, non-comparative, multicenter, observational study. The study included patients who met the inclusion/exclusion criteria and signed a written informed consent. The studied antibiotic: cefepime/sulbactam (Maxictam®-AF). The primary parameter for effectiveness evaluation was the clinical effect after the conclusion of cefepime/sulbactam therapy — recovery/improvement or no effect. Results. The study included 140 patients (average age — 60.8 years) who received at least one dose of cefepime/sulbactam; 37 of them had intraabdominal infection, 72 — NP, and 31 — VAP. Most of the included patients were in the ICU department (82.1%) and their condition was severe: the average APACHE II score was 15.5 points, SOFA — 5.4 points, the Mannheim peritonitis index value in patients with intra-abdominal infection was from 14 to 35 points, with an average of 24.3 points. The majority of patients treated with cefepime/sulbactam (68.6%) had one or more risk factors for multi-resistant pathogens upon hospital or ICU admission. Cefepime/sulbactam was prescribed as the 1st or 2nd line of empirical therapy at a daily dose of 4 g (in 68.3%), 6 g (2.9%) or 8 g (28.8%); most patients were prescribed cefepime/sulbactam in monotherapy (72.3%). The average duration of therapy with cefepime/sulbactam was 9.6±3.5 days. The final assessment of treatment effectiveness was carried out in 132 patients: recovery or improvement was noted in 80.6% of patients with intra-abdominal infection, the effectiveness in NP and VAP was slightly higher — 95.6 and 89.3%. The effect was absent in 5.3% of patients, relapse or superinfection was noted in 3.0 and 1.5%. The majority of patients (81.3%) treated with cefepime/sulbactam were discharged from the hospital. No serious side effects were observed. In patients with a positive effect, age and values of APACHE II were significantly lower (59.58 years and 14.79 points) compared to those with no effect (67.95 years and 18.39 points). A multivariate analysis found that the probability of recovery of patients treated with cefepime/sulbactam did not depend on the diagnosis of infection, ICU admission, the presence of sepsis or septic shock. Conclusion. The multicenter study has established a high clinical efficacy of cefepime/sulbactam in real clinical practice in the treatment of patients with severe intraabdominal infection, nosocomial pneumonia or ventilator-associated pneumonia.
This review focuses on the practical aspects of prevention and treatment of fungal infections in surgical patients. It covers epidemiology and risk factors for invasive candidiasis, updates on the etiological structure of fungal infections in patients in critical conditions, and provides the information on drug sensitivity of Candida species. The authors discuss the limitations of cultural and non-cultural diagnostic methods used in invasive candidiasis, emphasizing the importance of analyzing the existing risk factors in combination with a comprehensive assessment of clinical and laboratory data for timely initiation of adequate antifungal therapy. The review provides a brief description of currently available antimicotics, including polyenes, triazoles, and echinocandins. It also describes the benefits of anidulafungin, which does not interact with other drugs and has no negative effect on the liver and kidney. The article also covers indications for antifungal agents in surgical intensive care units in accordance with international and Russian guidelines. A cohort of patients with abdominal diseases requiring preventive and empirical treatment with antimicotics is described. In additions to that, the manuscript contains a rationale for the use of echinocandins in targeted therapy of invasive candidiasis.
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