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Insmed Incorporated Message Board

  • fudfighter4 fudfighter4 Mar 11, 2013 10:28 AM Flag

    Approval of Arikace for Klebsiella and E.coli

    The following info is from a study at Sultan Qaboos University Hospital from July 2005 to July 2007 of antibiotic resistance via extended spectrum beta-lactamases (ESBLs), during which they identified 301 ESBL-producing Escherichia coli and K. pneumoniae strains isolated from clinical samples -

    Overall Piperacillin-Tazobactam susceptibility was 57.9 (64.4% E. coli and 43.6% Klebsiella pneumoniae).

    Only 29.6 % of ESBLs (24.9% E. coli and 39.6% Klebsiella pneumoniae) were ciprofloxacin susceptible.

    98.1% E. coli and 93.1% of Klebsiella pneumoniae were susceptible to Piperacillin-Tazobactam plus Amikacin combination.

    73.7% E. coli and 61.4% of Klebsiella pneumoniae were susceptible to Piperacillin-Tazobactam plus Gentamicin combination.

    96.7% E. coli and 91.1% of Klebsiella pneumoniae were susceptible to Ciprofloxacin plus Amikacin combination.

    41.2% E. coli and 51.5% of Klebsiella pneumoniae were susceptible to Ciprofloxacin plus Gentamicin combination.

    "Conclusion: The ESBLs from Oman have similar resistance pattern as those reported from UK and USA. This resistance decreases when these drugs are combined with Amikacin. All ESBLs are susceptible to Carbapenems. However, carbepenam overuse can lead to emergence of carbapenems resistant gram negative bacilli and ESBLs.

    Combination of Amikacin plus Piperacillin/Tazobactam is a feasible empirical therapy for ESBLs."

    The reference to "empirical therapy" is key - emergency antibiotic treatment provided at a point when the pathogen has yet to be identified via laboratory analysis. From that FDA-sponsored workshop last year on Non-CF bronchiectasis -

    "in the unit, in the hospital, we frequently double coverage people with pseudomonal pneumonia, for example, or gram-negative pneumonia, or just empirically before we know what anything is. And a patient with a ventilator-associated pneumonia, or just a rip-roaring severe pseudomonal pneumonia, often gets two drugs of a different class"

    Arikace would act much faster.

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    • When it comes to amikacin for treating pneumonia, Bayer along with collaborators Novartis and Nectar filed to do a phase III study of inhaled amikacin solution way back in 2008. They then changed it 30 times (honest), before filing a completely new application last month. Not sure what that means, other than the fact that Fud isn't the only one that believes amikacin would be good at fighting pneumonia.

      I don't know whether or not the liposome composition would make our drug better than Bayer's inhaled solution, but I would tend to believe that it would.

    • 1. ECCMID April 2012 -

      "The addition of a short-course of high-dose aminoglycoside to initial antipseudomonal beta-lactam therapy can improve the treatment of healthcare-associated pneumonia by shortening the length of hospital stay, researchers said here at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

      Limited treatment options and delays in empiric therapy for multidrug resistant gram-negative organisms (MDR-Gn) are said to be largely to blame for the unsettling rise in such infections, causing increased lengths of stay, costs, and mortality resulting with infections.

      Healthcare-associated pneumonia has been shown to be associated with particularly resistant pathogens, and a combination therapy in which aminoglycoside is added to antipseudomonal beta-lactam has been suggested to improve treatment and resolve symptoms faster than monotherapy.

      In testing the efficacy of the combination therapy, researchers evaluated a group of 227 geriatric patients with nursing home acquired pneumonia, in which 104 patients received a combination therapy of antipseudomonal beta-lactam plus aminoglycoside and 123 received beta-lactam therapy without an aminoglycoside between 2009 and 2010.

      The results showed that the combination aminoglycoside therapy group had a mean length of stay that was 1.83 days shorter than the non-combination therapy group, resulting in lower overall inpatient costs."

      2. WHO August 2012 -

      "Pneumonia kills an estimated 1.4 million children under the age of five years every year"

      3. American Thoracic Society -

      "Worldwide, TB is the dominant HIV-associated pneumonia, and it is estimated that one-third of the world's population is infected with Mycobacterium tuberculosis."

      4. CDC -

      "In 2009, 1.1 million people in the United States were hospitalized with pneumonia and more than 50,000 people died from the disease."

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