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      Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE

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          Abstract

          Background

          Pooled data from two large registries, Cubicin ® Outcomes Registry and Experience (CORE; USA) and European Cubicin ® Outcomes Registry and Experience (EU-CORE; Europe, Latin America, and Asia), were analyzed to determine the characteristics and clinical outcomes of daptomycin therapy in patients with Gram-positive infections across wide geographical regions.

          Methods

          Patients receiving at least one dose of daptomycin between 2004 and 2012 for the treatment of Gram-positive infections were included. Clinical success was defined as an outcome of ‘cured’ or ‘improved’. Post-treatment follow-up data were collected for a subset of patients (CORE: osteomyelitis and orthopedic foreign body device infection; EU-CORE: endocarditis, intracardiac/intravascular device infection, osteomyelitis, and orthopedic device infection). Safety was assessed for up to 30 days after daptomycin treatment.

          Results

          In 11,557 patients (CORE, 5482; EU-CORE, 6075) treated with daptomycin (median age, 62 [range, 1–103] years), the most frequent underlying conditions were cardiovascular disease (54.7 %) and diabetes mellitus (28.0 %). The most commonly treated primary infections were complicated skin and soft tissue infection (cSSTI; 31.2 %) and bacteremia (21.8 %). The overall clinical success rate was 77.2 % (uncomplicated SSTI, 88.3 %; cSSTI, 81.0 %; osteomyelitis, 77.7 %; foreign body/prosthetic infection (FBPI), 75.9 %; endocarditis, 75.4 %; and bacteremia, 69.5 %). The clinical success rate was 79.1 % in patients with Staphylococcus aureus infections (MRSA, 78.1 %). An increasing trend of high-dose daptomycin (>6 mg/kg/day) prescribing pattern was observed over time. Clinical success rates were higher with high-dose daptomycin treatment for endocarditis and FBPI. Adverse events (AEs) and serious AEs possibly related to daptomycin therapy were reported in 628 (5.4 %) and 133 (1.2 %) patients, respectively.

          Conclusions

          The real-world data showed that daptomycin was effective and safe in the treatment of various Gram-positive infections, including those caused by resistant pathogens, across wide geographical regions.

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          Most cited references50

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          Community-associated methicillin-resistant Staphylococcus aureus: epidemiology and clinical consequences of an emerging epidemic.

          Staphylococcus aureus is an important cause of skin and soft-tissue infections (SSTIs), endovascular infections, pneumonia, septic arthritis, endocarditis, osteomyelitis, foreign-body infections, and sepsis. Methicillin-resistant S. aureus (MRSA) isolates were once confined largely to hospitals, other health care environments, and patients frequenting these facilities. Since the mid-1990s, however, there has been an explosion in the number of MRSA infections reported in populations lacking risk factors for exposure to the health care system. This increase in the incidence of MRSA infection has been associated with the recognition of new MRSA clones known as community-associated MRSA (CA-MRSA). CA-MRSA strains differ from the older, health care-associated MRSA strains; they infect a different group of patients, they cause different clinical syndromes, they differ in antimicrobial susceptibility patterns, they spread rapidly among healthy people in the community, and they frequently cause infections in health care environments as well. This review details what is known about the epidemiology of CA-MRSA strains and the clinical spectrum of infectious syndromes associated with them that ranges from a commensal state to severe, overwhelming infection. It also addresses the therapy of these infections and strategies for their prevention.
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            General Principles of Antimicrobial Therapy

            Antimicrobial agents are some of the most widely, and often injudiciously, used therapeutic drugs worldwide. Important considerations when prescribing antimicrobial therapy include obtaining an accurate diagnosis of infection; understanding the difference between empiric and definitive therapy; identifying opportunities to switch to narrow-spectrum, cost-effective oral agents for the shortest duration necessary; understanding drug characteristics that are peculiar to antimicrobial agents (such as pharmacodynamics and efficacy at the site of infection); accounting for host characteristics that influence antimicrobial activity; and in turn, recognizing the adverse effects of antimicrobial agents on the host. It is also important to understand the importance of antimicrobial stewardship, to know when to consult infectious disease specialists for guidance, and to be able to identify situations when antimicrobial therapy is not needed. By following these general principles, all practicing physicians should be able to use antimicrobial agents in a responsible manner that benefits both the individual patient and the community.
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              Vancomycin-resistant Staphylococcus aureus in the United States, 2002-2006.

              This report compares the clinical characteristics, epidemiologic investigations, infection-control evaluations, and microbiologic findings of all 7 of the cases of vancomycin-resistant Staphylococcus aureus (VRSA) infection in the United States during the period 2002-2006. Epidemiologic, clinical, and infection-control information was collected. VRSA isolates underwent confirmatory identification, antimicrobial susceptibility testing, pulsed-field gel electrophoresis, and typing of the resistance genes. To assess VRSA transmission, case patients and their contacts were screened for VRSA carriage. Seven cases were identified from 2002 through 2006; 5 were reported from Michigan, 1 was reported from Pennsylvania, and 1 was reported from New York. All VRSA isolates were vanA positive and had a median vancomycin minimum inhibitory concentration of 512 microg/mL. All case patients had a history of prior methicillin-resistant S. aureus and enterococcal infection or colonization; all had several underlying conditions, including chronic skin ulcers; and most had received vancomycin therapy prior to their VRSA infection. Person-to-person transmission of VRSA was not identified beyond any of the case patients. Infection-control precautions were evaluated and were consistent with established guidelines. Seven patients with vanA-positive VRSA have been identified in the United States. Prompt detection by microbiology laboratories and adherence to recommended infection control measures for multidrug-resistant organisms appear to have prevented transmission to other patients.
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                Author and article information

                Contributors
                andrew.seaton@ggc.scot.nhs.uk
                armando.gonzalez@nhs.net
                kclevel1@uthsc.edu
                kim_couch@yahoo.com
                rashidkhan.pathan@novartis.com
                kamal.hamed@novartis.com
                Journal
                Ann Clin Microbiol Antimicrob
                Ann. Clin. Microbiol. Antimicrob
                Annals of Clinical Microbiology and Antimicrobials
                BioMed Central (London )
                1476-0711
                15 March 2016
                15 March 2016
                2016
                : 15
                : 18
                Affiliations
                [ ]Queen Elizabeth University Hospital, Glasgow, UK
                [ ]Darent Valley Hospital, Dartford, UK
                [ ]University of Tennessee Health Science Center, Memphis, TN USA
                [ ]Infectious Diseases Pharmacy Associates, Inc., Stevensville, MD USA
                [ ]Novartis Healthcare Pvt. Ltd., Hyderabad, India
                [ ]Novartis Pharmaceuticals Corporation, East Hanover, NJ USA
                Author information
                http://orcid.org/0000-0003-1896-9736
                Article
                130
                10.1186/s12941-016-0130-8
                4791778
                26976128
                3c71da4a-ff81-44b3-836e-842f6d776057
                © Seaton et al. 2016

                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
                : 25 November 2015
                : 29 February 2016
                Funding
                Funded by: Cubist
                Funded by: FundRef http://dx.doi.org/10.13039/100008792, Novartis Pharma;
                Categories
                Research
                Custom metadata
                © The Author(s) 2016

                Infectious disease & Microbiology
                core,daptomycin,efficacy,eu-core,gram-positive infections,high dose,mrsa,real-world,safety,staphylococcus aureus

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