International Health Management Associates Inc.

Schaumburg, IL, United States

International Health Management Associates Inc.

Schaumburg, IL, United States

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Cubist Pharmaceuticals Inc., International Health Management Associates Inc. and University of Utah | Date: 2010-12-22

The present invention provides compositions and methods for increasing absorption of antibacterial agents, particularly third generation cephalosporin antibacterial agents, in oral dosage solid and/or suspension forms. Specifically, the composition is comprised of a biopolymer that is preferably swellable and/or mucoadhesive, an antimicrobial agent, and a cationic binding agent contained within the biopolymer such that the binding agent is ionically bound or complexed to at least one member selected from the group consisting of the biopolymer and the antimicrobial agent.


Biedenbach D.J.,International Health Management Associates Inc. | Kazmierczak K.,International Health Management Associates Inc. | Bouchillon S.K.,International Health Management Associates Inc. | Sahm D.F.,International Health Management Associates Inc. | Bradford P.A.,Astrazeneca
Antimicrobial Agents and Chemotherapy | Year: 2015

The combination of aztreonam plus avibactam is being developed for use in infections caused by metallo-β-lactamase-producing Enterobacteriaceae strains that also produce serine β-lactamases. The in vitro activities of aztreonam-avibactam and comparator antimicrobials were determined against year 2012 and 2013 clinical isolates of Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii using the broth microdilution methodology recommended by the Clinical and Laboratory Standards Institute (CLSI). A total of 28,501 unique clinical isolates were obtained from patients in 190 medical centers within 39 countries. MIC90 values of aztreonam and aztreonam-avibactam against all collected isolates of Enterobacteriaceae (n = 23,516) were 64 and 0.12 μg/ml, respectively, with 76.2% of the isolates inhibited by ≤4 μg/ml of aztreonam (the CLSI breakpoint) and 99.9% of the isolates inhibited by ≤4 μg/ml of aztreonam-avibactam using a fixed concentration of 4 μg/ml of avibactam. The MIC90 was 32 μg/ml for both aztreonam and aztreonam-avibactam against P. aeruginosa (n = 3,766). Aztreonam alone or in combination with avibactam had no in vitro activity against isolates of A. baumannii. PCR and sequencing were used to characterize 5,076 isolates for β-lactamase genes. Aztreonam was not active against most Enterobacteriaceae isolates producing class A or class C enzymes alone or in combination with class B metallo-β-lactamases. In contrast, >99% of Enterobacteriaceae isolates producing all observed Ambler classes of β-lactamase enzymes were inhibited by ≤4 μg/ml aztreonam in combination with avibactam, including isolates that produced IMP-, VIM-, and NDM-type metallo-β-lactamases in combination with multiple serine β-lactamases. Copyright © 2015, American Society for Microbiology. All Rights Reserved.


Hawser S.P.,IHMA Europe Sarl | Badal R.E.,International Health Management Associates Inc. | Bouchillon S.K.,International Health Management Associates Inc. | Hoban D.J.,International Health Management Associates Inc. | And 3 more authors.
Journal of Infection | Year: 2014

Objectives: During 2011, a total of 1442 gram-negative pathogens from intra-abdominal infections were collected as part of the Study for Monitoring Antimicrobial Resistance Trends (SMART) from 19 hospital sites within the United States. Susceptibility to ertapenem and comparators and molecular analysis of ertapenem resistant isolates was performed. Methods: Extended-spectrum beta-lactamase ESBL (ESBL) isolates were determined using the Clinical and Laboratory Standards Institute's recommended phenotypic test. Isolates were identified to the species level, and tested for antimicrobial susceptibility using custom MicroScan dehydrated broth microdilution panels ESBLs and carbapenemases were characterized using the Check-Points microarray. Strain typing of Klebsiella pneumoniae was performed by rep-PCR on the DiversiLab System. Results: The majority of isolates were Escherichia coli (36%), K. pneumoniae (18.6%), Pseudomonas aeruginosa (12.1%) and Enterobacter cloacae (8.4%). Incidence of ESBL-positive isolates was 12.7%, 9.7%, 3.6% and 3.1% for K. pneumoniae, E. coli, Proteus mirabilis and Klebsiella oxytoca, respectively. Against the majority of isolates and species tested, the most active antibiotics were amikacin, ertapenem, and imipenem, with the carbapenems being the most active invitro, including against ESBL-positive isolates of E. coli. All other antibiotics exhibited diminished activity. Against K. pneumoniae, the carbapenems were notably less active against ESBL-positive isolates though their activity against this sub-population was still the highest of all antibiotics tested; however, 41.1% (14 of 34) of the phenotypically ESBL-positive K. pneumoniae co-produced a carbapenemase (KPC2 or KPC3), and >90% of the isolates producing only an ESBL remained susceptible to ertapenem. Conclusions: Further monitoring of susceptibility of intra-abdominal isolates is warranted due to limited therapeutic options available to physicians. © 2013 The British Infection Association.


Lascols C.,International Health Management Associates Inc. | Peirano G.,University of Calgary | Hackel M.,International Health Management Associates Inc. | Laupland K.B.,University of Calgary | Pitout J.D.D.,University of Calgary
Antimicrobial Agents and Chemotherapy | Year: 2013

A study was designed to characterize nonrepeat isolates of carbapenemase-producing K. pneumoniae obtained from the SMART worldwide surveillance program during 2008 and 2009. Characterization was done by PCR and sequencing for blaVIM, blaIMP, blaNDM, bla OXA, blaKPC, and plasmid-mediated quinolone resistance and virulence factors (VFs). Genetic relatedness was determined with pulsed-field gel electrophoresis (PFGE) using XbaI and multilocus sequence typing. A total of 110 isolates were included; 47 possess genes that encode K. pneumoniae carbapenemases (KPCs), 26 NDMs, 19 VIMs, 13 OXA-48-like, and 5 imipenems (IMPs). We identified 3 different major sequence types (STs) among 65% of the isolates (i.e., ST11 [ n = 11], ST147 [n = 23], and ST258 [n = 38]). ST11 and ST147, producing OXA-48-like and NDMs, were found in Argentina, Turkey, Greece, Italy, and India; ST258, producing KPCs, was present in the United States, Israel, Greece, and Puerto Rico. The major STs consisted of up to 4 different pulsotypes, and each pulsotype had a specific geographical distribution. A new ST, named ST903, with blaIMP-26, was identified in the Philippines, while two blaOXA-48-positive isolates were detected in the United States. There were no significant differences in the distribution of the VFs between the isolates; all were positive for fimH, mrkD, wabG, and ureA. This is the first report of OXA-48-like enzymes in North America. Our study highlights the importance of surveillance programs using molecular techniques as powerful tools to identify the importance of international sequence types. Copyright © 2013, American Society for Microbiology. All Rights Reserved.


Peirano G.,University of Calgary | Lascols C.,International Health Management Associates Inc. | Hackel M.,International Health Management Associates Inc. | Hoban D.J.,International Health Management Associates Inc. | And 2 more authors.
Diagnostic Microbiology and Infectious Disease | Year: 2014

A study was designed to characterize 35 non-repeat isolates of VIM- and IMP-producing Enterobacteriaceae obtained from the SMART surveillance program. Characterization was done by polymerase chain reaction, sequencing, and multi-locus sequencing. The VIM-1, -2, -5, -26, -27, -33, and IMP-1 and -26-producing Enterobacteriaceae were obtained from Greece, Italy, Spain, Philippines, Turkey, Australia, Mexico, USA, and India. Plasmids varied in size from 60 to 300 kb and belonged to IncA/C, IncF, IncHI1, IncL/M, IncN, and IncK incompatibility groups. The most common gene cassettes consisted of blaIMP-26, qacG, aacA4 and blaVIM, aacA7, dhfrI, and aadA1. Intercountry, interhospital, intrahospital, interspecies, and intraclonal spread of blaVIM and blaIMP containing plasmids and sequence types (STs) occurred in Greece, Italy, Spain, and Philippines. ST147 with IncA/C and IncF plasmids is an important drug-resistant ST among Klebsiella pneumoniae with VIMs. Our study highlights the importance of surveillance programs using molecular techniques as powerful tools to identify the transmission of STs with their respective plasmids. © 2014 Elsevier Inc.


Biedenbach D.,International Health Management Associates Inc. | Bouchillon S.,International Health Management Associates Inc. | Hackel M.,International Health Management Associates Inc. | Hoban D.,International Health Management Associates Inc. | And 3 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2015

The prevalence of carbapenemase enzymes continues to increase. Among the Ambler class B enzymes is the New Delhi metallo- β-lactamase (NDM). This particular enzyme is capable of hydrolyzing nearly all -lactam antimicrobial agents and has spread rapidly, becoming a global problem. Therapeutic treatment options for patients infected with isolates which produce this enzyme are difficult to manage, as cross-resistance to other antimicrobial classes is common. The Study for Monitoring Antimicrobial Resistance Trends (SMART) is a global surveillance study evaluating the antimicrobial susceptibilities of numerous Gramnegative bacterial species recovered from people with intra-abdominal and urinary tract infections. The Clinical and Laboratory Standards Institute methods and a molecular analysis identified 134 isolates of Enterobacteriaceae (nine species) and one Acinetobacter sp. with blaNDM genes. These isolates were collected in nine countries, and >95% of the isolates possessed the NDM-1 variant. The MIC90 values were >4 mg/liter and >8 mg/liter for ertapenem and imipenem, respectively. No tested β-lactam or β-lactamase inhibitor combination had activity against these isolates. Resistance to amikacin (79.9%) and levofloxacin (82.8%) was common. Nearly all the isolates encoded additional enzymes, including AmpC cephalosporinases and extended-spectrum β-lactamases. There is an urgent need for infection control and continued global monitoring of isolates which harbor the NDM enzyme, as evidenced by recent outbreaks. © 2015 American Society for Microbiology.


Bouchillon S.K.,International Health Management Associates Inc. | Badal R.E.,International Health Management Associates Inc. | Hoban D.J.,International Health Management Associates Inc. | Hawser S.P.,IHMA Europe Sarl
Clinical Therapeutics | Year: 2013

Background: The Study for Monitoring Antimicrobial Resistance Trends is an ongoing global surveillance program that has monitored the susceptibilities of Gram-negative bacilli from inpatient urinary tract infections (UTIs) since late 2009. Objective: This analysis reports on the in vitro susceptibility of 2,135 isolates collected by 24 US sites from hospitalized patients with UTIs between 2009 and 2011. Methods: Minimum inhibitory concentrations and susceptibility were determined according to the guidelines of the Clinical and Laboratory Standards Institute. Results: Of the isolates collected, 88.6% (1,892) were Enterobacteriaceae, which included 48.9% (n = 1,045) Escherichia coli, 14.5% (n = 310) Klebsiella pneumoniae, 6.4% (n = 136) Proteus mirabilis, 2.5% (n = 54) Klebsiella oxytoca, and 16.3% (n = 347) other Enterobacteriaceae species. Overall, 6.8% of E coli, 10.3% of K pneumoniae, 3.7% of P mirabilis, and 11.1% of K oxytoca isolates were extended-spectrum β-lactamase-producing strains. Of the Enterobacteriaceae isolates, 67.5% were community associated and 26.9% were hospital associated (5.7% had no demographics). Highest overall rates of activity for the study period were seen with amikacin, ertapenem, and imipenem. The least active antimicrobials tested were ampicillin-sulbactam, ciprofloxacin, and levofloxacin. Conclusions: Ertapenem, imipenem, and amikacin were the most active study drugs against extended-spectrum β-lactamase-producing strains, although the activity against extended-spectrum β-lactamase-producing K pneumoniae did not exceed 69% throughout the study period. The results of the Study for Monitoring Antimicrobial Resistance Trends surveillance study document the rates of antimicrobial resistance in UTI pathogens in the United States, which can assist health care practitioners in selecting the appropriate treatment for UTIs. © 2013.


Lob S.H.,International Health Management Associates Inc. | Kazmierczak K.M.,International Health Management Associates Inc. | Badal R.E.,International Health Management Associates Inc. | Hackel M.A.,International Health Management Associates Inc. | And 3 more authors.
Antimicrobial Agents and Chemotherapy | Year: 2015

Antimicrobial resistance in Enterobacteriaceae, including resistance to carbapenems, is increasing worldwide. However, using U.S. Study for Monitoring Antimicrobial Resistance Trends (SMART) data for 2009 to 2013, no statistically significant decreasing susceptibility trends were found overall for Escherichia coli isolates from patients with intra-abdominal infections. In the subset of isolates from community-associated infections, susceptibility to levofloxacin decreased significantly and the increasing rate of multidrug-resistant E. coli approached statistical significance. In 2013, ertapenem, imipenem, and amikacin showed the highest susceptibility rates (≥99%) and fluoroquinolones the lowest (<70%). The 10 non-ertapenem-susceptible isolates (0.3% of all E. coli isolates) encoded one or more carbapenemases, extended-spectrum β-lactamases (ESBLs), AmpC β-lactamases, or non-ESBL β-lactamases. Copyright © 2015, American Society for Microbiology. All Rights Reserved.


Doyle D.,Calgary Laboratory Services | Peirano G.,Calgary Laboratory Services | Peirano G.,University of Calgary | Lascols C.,International Health Management Associates Inc. | And 5 more authors.
Journal of Clinical Microbiology | Year: 2012

A study was designed to evaluate the modified Hodge test (MHT), Mastdiscs ID inhibitor combination disks (MDI), Rosco Diagnostica Neo-Sensitabs (RDS), metallo-β-lactamase (MBL) Etest, and in-house multiplex PCR for the detection of well-characterized carbapenemase-producing Enterobacteriaceae. One hundred forty-two nonrepeat clinical isolates of carbapenemase-producing Enterobacteriaceae (including Klebsiella spp., Escherichia coli, Citrobacter freundii, and Enterobacter spp.) obtained from the SMART worldwide surveillance program during 2008 to 2009 were included. These included 49 KPC-, 27 NDM-, 19 VIM-, 14 OXA-48-like enzyme-, and 5 IMP-producing isolates and 28 carbapenem-resistant, carbapenemase-negative isolates. The manufacturer's instructions were followed for MDI, RDS, and MBL Etest and CLSI guidelines for MHT. A multiplex PCR was designed to detect KPC, NDM, VIM, IMP, and OXA-48-like carbapenemases. Overall, the sensitivity and specificity were 78% and 93% for MDI, 80% and 93% for RDS, 58% and 93% for MHT, and 55% and 100% for MBL Etest, respectively. The PCR had 100% sensitivity and specificity. MDI and RDS performed well for the detection of KPCs and NDMs but poorly for VIMs, IMPs, and OXA-48-like enzymes. MHT performed well for KPCs and OXA-48-like enzymes but poorly for NDMs, VIMs, and IMPs. MDI and RDS were easy to perform and interpret but lacked sensitivity for OXA-48-like enzymes, VIMs, and IMPs. MHT and MBL Etest were often difficult to interpret. We recommend using molecular tests for the optimal detection of carbapenemase-producing Enterobacteriaceae. Copyright © 2012, American Society for Microbiology. All Rights Reserved.


Hoban D.J.,International Health Management Associates Inc. | Nicolle L.E.,University of Manitoba | Hawser S.,IHMA Europe Sarl | Bouchillon S.,International Health Management Associates Inc. | Badal R.,International Health Management Associates Inc.
Diagnostic Microbiology and Infectious Disease | Year: 2011

Escherichia coli is the most important uropathogen. The Study for Monitoring Antimicrobial Resistance Trends program collected 1643 E. coli isolates in 2009-2010 from urinary tract infection (UTI) specimens of hospitalized patients in countries worldwide. Ertapenem and imipenem were the most active agents tested, inhibiting >98% of all E. coli phenotypes. Overall, 17.9% of isolates were extended-spectrum beta-lactamase (ESBL) producers. The highest ESBL rate was from the Asia/Pacific region (27.7%). Amikacin and piperacillin-tazobactam achieved 90% inhibition levels only for ESBL-negative isolates. Ciprofloxacin and levofloxacin were not effective for ESBL-positive isolates, with only 14.6% and 15.9% susceptible, respectively. These observations highlight the need for continued monitoring of susceptibility of E. coli isolated from hospitalized patients with UTIs. © 2011 Elsevier Inc.

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