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      Double carbapenem as a rescue strategy for the treatment of severe carbapenemase-producing Klebsiella pneumoniae infections: a two-center, matched case–control study

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          Abstract

          Background

          Recent reports have suggested the efficacy of a double carbapenem (DC) combination, including ertapenem, for the treatment of carbapenem-resistant Klebsiella pneumoniae (CR- Kp) infections. We aimed to evaluate the clinical impact of such a regimen in critically ill patients.

          Methods

          This case–control (1:2), observational, two-center study involved critically ill adults with a microbiologically documented CR- Kp invasive infection treated with the DC regimen matched with those receiving a standard treatment (ST) (i.e., colistin, tigecycline, or gentamicin).

          Results

          The primary end point was 28-day mortality. Secondary outcomes were clinical cure, microbiological eradication, duration of mechanical ventilation and of vasopressors, and 90-day mortality. Forty-eight patients treated with DC were matched with 96 controls. Occurrence of septic shock at infection and high procalcitonin levels were significantly more frequent in patients receiving DC treatment ( p < 0.01). The 28-day mortality was significantly higher in patients receiving ST compared with the DC group (47.9% vs 29.2%, p = 0.04). Similarly, clinical cure and microbiological eradication were significantly higher when DC was used in patients infected with CR- Kp strains resistant to colistin (13/20 (65%) vs 10/32 (31.3%), p = 0.03 and 11/19 (57.9%) vs 7/27 (25.9%), p = 0.04, respectively). In the logistic regression and multivariate Cox-regression models, the DC regimen was associated with a reduction in 28-day mortality (OR 0.33, 95% CI 0.13–0.87 and OR 0.43, 95% CI 0.23–0.79, respectively).

          Conclusions

          Improved 28-day mortality was associated with the DC regimen compared with ST for severe CR- Kp infections. A randomized trial is needed to confirm these observational results.

          Trial registration

          ClinicalTrials.gov NCT03094494. Registered 28 March 2017.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13054-017-1769-z) contains supplementary material, which is available to authorized users.

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          Most cited references31

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          A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study.

          To develop and validate a new Simplified Acute Physiology Score, the SAPS II, from a large sample of surgical and medical patients, and to provide a method to convert the score to a probability of hospital mortality. The SAPS II and the probability of hospital mortality were developed and validated using data from consecutive admissions to 137 adult medical and/or surgical intensive care units in 12 countries. The 13,152 patients were randomly divided into developmental (65%) and validation (35%) samples. Patients younger than 18 years, burn patients, coronary care patients, and cardiac surgery patients were excluded. Vital status at hospital discharge. The SAPS II includes only 17 variables: 12 physiology variables, age, type of admission (scheduled surgical, unscheduled surgical, or medical), and three underlying disease variables (acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy). Goodness-of-fit tests indicated that the model performed well in the developmental sample and validated well in an independent sample of patients (P = .883 and P = .104 in the developmental and validation samples, respectively). The area under the receiver operating characteristic curve was 0.88 in the developmental sample and 0.86 in the validation sample. The SAPS II, based on a large international sample of patients, provides an estimate of the risk of death without having to specify a primary diagnosis. This is a starting point for future evaluation of the efficiency of intensive care units.
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            Clinical Outcomes, Drug Toxicity, and Emergence of Ceftazidime-Avibactam Resistance Among Patients Treated for Carbapenem-Resistant Enterobacteriaceae Infections.

            Thirty-seven carbapenem-resistant Enterobacteriaceae (CRE)-infected patients were treated with ceftazidime-avibactam. Clinical success and survival rates at 30 days were 59% (22/37) and 76% (28/37), respectively. In 23% (5/22) of clinical successes, CRE infections recurred within 90 days. Microbiologic failure rate was 27% (10/37). Ceftazidime-avibactam resistance was detected in 30% (3/10) of microbiologic failures.
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              Treating infections caused by carbapenemase-producing Enterobacteriaceae.

              Carbapenemase-producing Enterobacteriaceae (CPE) have spread worldwide, causing serious infections with increasing frequency. CPE are resistant to almost all available antibiotics, complicating therapy and limiting treatment options. Mortality rates associated with CPE infections are unacceptably high, indicating that the current therapeutic approaches are inadequate and must be revised. Here, we review 20 clinical studies (including those describing the largest cohorts of CPE-infected patients) that provided the necessary information regarding isolate and patient characteristics and treatment schemes, as well as a clear assessment of outcome. The data summarized here indicate that treatment with a single in vitro active agent resulted in mortality rates not significantly different from that observed in patients treated with no active therapy, whereas combination therapy with two or more in vitro active agents was superior to monotherapy, providing a clear survival benefit (mortality rate, 27.4% vs. 38.7%; p <0.001). The lowest mortality rate (18.8%) was observed in patients treated with carbapenem-containing combinations.
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                Author and article information

                Contributors
                + 39 06 30 15 4889 , gennaro.depascalemd@gmail.com
                gennaro.martucci@libero.it
                luca.montini@unicatt.it
                gpanarello@ismett.edu
                sl.cutuli@gmail.com
                ddicarlo@ismett.edu
                valentinadigravio@gmail.com
                rdistefano@ismett.edu
                gcapitanio@ismett.edu
                mariasole.vallecoccia@gmail.com
                ppolidori@ismett.edu
                teresa.spanu@unicatt.it
                aarcadipane@ismett.edu
                massimo.antonelli@unicatt.it
                Journal
                Crit Care
                Critical Care
                BioMed Central (London )
                1364-8535
                1466-609X
                5 July 2017
                5 July 2017
                2017
                : 21
                : 173
                Affiliations
                [1 ]ISNI 0000 0001 0941 3192, GRID grid.8142.f, Department of Anesthesiology and Intensive Care, , Università Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli, ; Rome, Italy
                [2 ]ISNI 0000 0001 2110 1693, GRID grid.419663.f, Department of Anesthesia and Intensive Care, , IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), ; Palermo, Italy
                [3 ]ISNI 0000 0001 2110 1693, GRID grid.419663.f, Department of Laboratory Medicine and Advanced Biotechnologies, , IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), ; Palermo, Italy
                [4 ]ISNI 0000 0001 2110 1693, GRID grid.419663.f, Clinical Pharmacy, , IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), ; Palermo, Italy
                [5 ]ISNI 0000 0001 0941 3192, GRID grid.8142.f, Institute of Microbiology, , Università Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli, ; Rome, Italy
                [6 ]ISNI 0000 0001 0941 3192, GRID grid.8142.f, , Fondazione Policlinico A. Gemelli. Università Cattolica del Sacro Cuore, ; Largo A. Gemelli 8, 00168 Rome, Italy
                Article
                1769
                10.1186/s13054-017-1769-z
                5498909
                28679413
                a50ef4ab-aa93-4293-a56d-e0d903f11425
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 6 April 2017
                : 20 June 2017
                Categories
                Research
                Custom metadata
                © The Author(s) 2017

                Emergency medicine & Trauma
                double carbapenem,klebsiella pneumoniae,critically ill patients,infections,multidrug-resistant bacteria,meropenem,ertapenem

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