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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThe resistance of infectious organisms to currently available antibiotics is a major medical challenge. The prevalence and mechanisms of multidrug-resistant pathogens vary widely worldwide. In the United States and Europe, the prevalence of methicillin-resistant \u003Cem\u003EStaphylococcus aureus\u003C\/em\u003E (MRSA) appears to have stabilized, while it is increasing in other regions [Dantes R et al. \u003Cem\u003EJAMA Intern Med\u003C\/em\u003E 2013]. Antibiotic resistance to gram-negative bacteria continues to increase and represents one of the biggest challenges.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EBacterial Infections\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDrug Resistance\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInfectious Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary \u0026amp; Respiratory Medicine\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe resistance of infectious organisms to currently available antibiotics is a major medical challenge. The prevalence and mechanisms of multidrug-resistant pathogens vary widely worldwide. In the United States and Europe, the prevalence of methicillin-resistant \u003Cem\u003EStaphylococcus aureus\u003C\/em\u003E (MRSA) appears to have stabilized, while it is increasing in other regions [Dantes R et al. \u003Cem\u003EJAMA Intern Med\u003C\/em\u003E 2013]. Key factors contributing to the magnitude of disease from resistant organisms are biological fitness of the organism, virulence, control techniques, and antibiotic stewardship. Antibiotic resistance to gram-negative bacteria (GNB) continues to increase and represents one of the biggest challenges, according to Mark L. Metersky, MD, University of Connecticut School of Medicine, Farmington, Connecticut, USA [Braykov NP et al. \u003Cem\u003EInfect Control Hosp Epidemiol\u003C\/em\u003E 2013].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe intensive control techniques required by the Danish government have led to a MRSA prevalence of only 1.4% [Agers\u00f8 Y et al. \u003Cem\u003EDANMAP\u003C\/em\u003E 2011; Danish National Board of Health, 2008]. Health care facilities are required to report all MRSA infections (even colonization), practice strict isolation in all settings, perform widespread testing of at-risk patients and exposed staff, and treat all colonized patients aggressively (mupirocin nasal ointment, chlorhexidine soap). Antibiotic stewardship should include determining the infecting organism, the appropriate initial antibiotic drug choice, the appropriate dosing, and the shorter duration of treatment.\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EADDRESSING THE DEVELOPMENT CHALLENGE\u003C\/h2\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EThe drought of antibiotics in the investigational pipeline resulted from regulatory, scientific, and economic issues, with current United States Food and Drug Administration (FDA) regulations being the predominant issue hampering drug development and making costs prohibitive, with low to negative return on investment.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EBrad Spellberg, MD, Harbor\u2013University of California Los Angeles Medical Center, Los Angeles, California, USA, proposed approaches to address these issues:\u003C\/p\u003E\n         \u003Cul class=\u0022list-simple \u0022 id=\u0022list-1\u0022\u003E\u003Cli id=\u0022list-item-1\u0022\u003E\n               \n               \u003Cp id=\u0022p-6\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003ETargeted therapies focused on unmet need\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-2\u0022\u003E\n               \n               \u003Cp id=\u0022p-7\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003ESmaller antibiotic development programs\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-3\u0022\u003E\n               \n               \u003Cp id=\u0022p-8\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003ENarrowing and restricting labeling and high pricing\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-4\u0022\u003E\n               \n               \u003Cp id=\u0022p-9\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003EShorter course of therapy\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-5\u0022\u003E\n               \n               \u003Cp id=\u0022p-10\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003ETreating infections without killing organisms\u003C\/p\u003E\n            \u003C\/li\u003E\u003C\/ul\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EThe era of broad-spectrum agents (eg, quinolones) to treat narrow-spectrum infections (skin infections, pneumococcal community-acquired pneumonia) should be over, said Dr. Spellberg. Recent guidance from the FDA has led to some development programs for unmet need. The FDA has stated a willingness to approve a new antibiotic drug with 2 indications from the conduct of 2 studies, rather than the previously required 4 studies, making this a more attractive proposition for drug companies. The targeted approach for unmet need will likely be more facile and less expensive and require less time than programs focused on large markets that can drive inappropriate use.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EOff-label use represents the majority of inappropriate antibiotic use in the United States, said Dr. Spellberg, which requires changes in labeling and pricing. The duration of treatment should be short\u2014only until the patient is better, as opposed to the current practice of complete prescription consumption, which lacks evidence of benefit and contributes to drug resistance.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EKilling bacteria promotes resistance; thus, there must be a shift to nonlethal methods, such as disarming bacteria, passively starving host nutrients, outcompeting with probiotics, and targeting the microbe\u2014not the host.\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EDr. Spellberg argued that the economic model for antibiotic drug development must change. In the United States, this may mean a public-private partnership model akin to defense contractors, where the government defrays much of the initial costs in the interest of public health with specification of industry profits.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EEFFECTIVE AND CONSERVATIVE ANTIMICROBIAL THERAPY\u003C\/h2\u003E\n         \u003Cp id=\u0022p-15\u0022\u003EThe agents currently used for antimicrobial therapy (AMT) must be used wisely to conserve them for the future, stated Jean Chastre, MD, Universite Pierre and Marie Curie, Paris, France. There are 3 approaches for this objective: using their pharmacokinetics (PK) and pharmacodynamics (PD) to improve outcomes, utilizing aerosolization for in situ delivery, and adjusting treatment for extensively drug-resistant (XDR) pathogens, which are primarily susceptible only to colistin.\u003C\/p\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EOf the difficult-to-treat pathogens, a small fraction of isolates are totally resistant; thus, the PK\/PD must be optimized to reach the available susceptibility. The time above the minimal inhibitory concentration (MIC) must be maintained for 80% to 100% of the dosing interval for time-dependent antibiotics such as penicillin and carbapenem for severe infections. Achieving this in patients in the intensive care unit (ICU) may be complicated by organ dysfunction and increased cardiac output secondary to sepsis, among other factors that may modify drug clearance [Roberts JA et al. \u003Cem\u003ELancet Infect Dis\u003C\/em\u003E 2014]. Thus, dose adjustment is required to avoid levels that are toxic or too low\u2014but with great caution because PK is altered in these patients. One study showed that achieving the MIC target for 100% of the dose was achieved in only 60.4% of ICU patients [Roberts JA et al. \u003Cem\u003EClin Infect Dis\u003C\/em\u003E 2014]. Strategies to improve PK\/PD parameters, including time above MIC, include use of a loading dose, prolonged duration of drug infusion to \u0026gt;4 hours (without underdosing), and continuous infusion, which was shown to improve survival in a Phase 2 trial [Dulhunty JM et al. \u003Cem\u003EClin Infect Dis\u003C\/em\u003E 2013]. Steps to optimize AMT in ICU patients are highlighted in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E [Roberts JA et al. \u003Cem\u003ELancet Infect Dis\u003C\/em\u003E 2014].\u003C\/p\u003E\n         \u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/14361\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/14361\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/14361\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-17\u0022 class=\u0022first-child\u0022\u003ERecommendations to Optimize Antimicrobial Treatment in the Intensive Care Unit\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-18\u0022\u003EColistin and possibly tigecycline are treatments for XDR GNB. Caution must be used with colistin because of nephro- and neurotoxicity and because of the different prescribing conventions (international units [IU]; number of milligrams of colistin base activity [CBA]) that can lead to dosing errors. One million IU is equivalent to 30-mg CBA and 80 mg of colistin methanesulfonate, which is the inactive prodrug form in which it is administered.\u003C\/p\u003E\n         \u003Cp id=\u0022p-19\u0022\u003EThe PK of colistin makes its use in ICU patients difficult because of renal clearance that affects blood concentration. A loading dose must be used to achieve required colistin concentrations [Plachouras D et al. \u003Cem\u003EAntimicrob Agents Chemother\u003C\/em\u003E 2009]. Combination therapy with colistin and a carbapenamase may be needed in some settings. Such a combination was strongly associated with survival (HR, 2.08; 95% CI, 1.23 to 3.51; p=0.006 vs monotherapy) in carbapenamase-producing \u003Cem\u003EKlebsiella pneumoniae\u003C\/em\u003E bloodstream infections in an observational study from Greece [Daikos GL et al. \u003Cem\u003EAntimicrob Agents Chemother\u003C\/em\u003E 2014].\u003C\/p\u003E\n         \u003Cp id=\u0022p-20\u0022\u003ETigecycline is a new and worthwhile treatment option, with activity against a variety of GNB, but it has minimal activity against \u003Cem\u003EPseudomonas aeruginosa, Pseudomonas mirabilis\u003C\/em\u003E, and indole-positive Proteaceae [Doan TL et al. \u003Cem\u003EClin Thea\u003C\/em\u003E 2006; Rose WE et al. \u003Cem\u003EPharmacotherapy\u003C\/em\u003E 2006]. Tigecycline should never be used for \u003Cem\u003EP aeruginosa\u003C\/em\u003E infection, stated Prof. Chastre, or for \u03b2-lactam-susceptible GNB.\u003C\/p\u003E\n         \u003Cp id=\u0022p-21\u0022\u003EAerosolized delivery of AMT as an adjunct to intravenous administration may address the low levels of lung penetration (\u0026lt;1\/3 of dose) obtained with conventional delivery, thus increasing drug concentration at the site of infection. Furthermore, direct delivery limits systemic exposure and allows the use of AMT with higher systemic toxicity, such as aminoglycosides or polymyxins [Luyt CE et al. \u003Cem\u003ECurr Opin Infect Dis\u003C\/em\u003E 2009]. Vibrating-mesh nebulizers are being developed to improve the efficiency of delivering the total aerosolized dose; current systems lose a majority of the dose in the device chamber.\u003C\/p\u003E\n         \u003Cp id=\u0022p-22\u0022\u003EIn summary, antibiotic resistance is a major medical challenge. Tackling this problem will likely require implementation of several strategies, including a policy of careful selection of antibiotic, route of administration and dosing schedule (shorter duration of effectively dosed therapy), and ongoing development of new agents, possibly supported by government programs.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/11\/28.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzp28d\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzp28d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}