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Clinical Therapeutics

Multicenter Observational Study of Ceftaroline Fosamil for Methicillin-Resistant Staphylococcus aureus Bloodstream Infections

Evan J. Zasowski, Trang D. Trinh, Kimberly C. Claeys, Anthony M. Casapao, Noor Sabagha, Abdalhamid M. Lagnf, Kenneth P. Klinker, Susan L. Davis, Michael J. Rybak
Evan J. Zasowski
aAnti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA
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Trang D. Trinh
aAnti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA
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Kimberly C. Claeys
aAnti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA
bDepartment of Pharmacy Practice, University of Maryland School of Pharmacy, Baltimore, Maryland, USA
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Anthony M. Casapao
aAnti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA
cDepartment of Pharmacy Practice, Husson University School of Pharmacy, Bangor, Maine, USA
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Noor Sabagha
aAnti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA
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Abdalhamid M. Lagnf
aAnti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA
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Kenneth P. Klinker
dUniversity of Florida, College of Pharmacy, Gainesville, Florida, USA
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Susan L. Davis
aAnti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA
eDepartment of Pharmacy Services, Henry Ford Hospital, Detroit, Michigan, USA
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Michael J. Rybak
aAnti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA
fDepartment of Medicine, Division of Infectious Diseases, School of Medicine, Wayne State University, Detroit, Michigan, USA
gDepartment of Pharmacy Services, Detroit Medical Center, Detroit, Michigan, USA
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DOI: 10.1128/AAC.02015-16
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    FIG 1

    Kaplan-Meier curves for the time to clearance of bloodstream infection post-ceftaroline initiation in the efficacy population. (A) Ceftaroline monotherapy; (B) ceftaroline combination therapy.

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  • TABLE 1

    Baseline demographics, clinical characteristics, and outcomes of the efficacy population

    ParameterValue for group
    Overall (n = 126)Monotherapy (n = 89)Combination therapy (n = 37)
    Demographics
        Median age (yr) (IQR)59 (45.5–66.8)59 (48–67)57 (45–66.5)
        No. of male patients (%)70 (55.6)50 (56.2)20 (54.1)
        No. of patients of race (%)
            African American86 (68.3)62 (69.7)24 (64.9)
            Caucasian34 (27.0)21 (23.6)13 (35.1)
            Hispanic/Latino1 (0.8)1 (1.1)0
            Other5 (4.0)5 (5.6)0
        No. of patients in hospital system (%)
            Detroit Medical Center83 (65.9)52 (58.4)31 (83.8)
            UF Health-Shands Hospital30 (23.8)26 (29.2)4 (10.8)
            Henry Ford Hospital13 (10.3)11 (12.4)2 (5.4)
    Comorbidities and past medical history
        No. of patients with comorbidity or past medical history (%)
            Prior antibiotics (90 days)33 (26.2)24 (27.0)9 (24.3)
            Prior MRSA infection (1 yr)20 (15.9)14 (15.7)6 (16.2)
            Obesity48 (38.1)37 (41.6)11 (29.7)
            Diabetes mellitus47 (37.3)34 (38.2)13 (35.1)
            Chronic kidney disease34 (27.0)25 (28.1)9 (24.3)
            Chronic hemodialysis26 (20.6)19 (21.3)7 (18.9)
            Liver disease20 (15.9)13 (14.6)7 (18.9)
            Intravenous drug user24 (19.0)14 (15.7)10 (27.0)
            Malignancy7 (5.6)4 (4.5)3 (8.1)
            HIV/AIDS8 (6.3)3 (3.4)5 (13.5)
            Neutropeniaa3 (2.4)2 (2.2)1 (2.7)
        Median Charlson comorbidity index (IQR)3 (2–5)3 (2–5)3 (2–5)
    Clinical characteristics
        No. of patients in intensive care unit (%)b45 (35.7)31 (34.8)14 (37.8)
        Median APACHE II score (IQR)b16 (12–22)16 (12–22)16 (13–22)
        No. (%) of patients with:
            Lower respiratory tract source41 (32.5)30 (33.7)11 (29.7)
            Infective endocarditis source31 (24.6)20 (22.5)11 (29.7)
            Bone/joint source26 (20.6)20 (22.5)6 (16.2)
            Intravenous catheter source20 (15.9)16 (18.0)4 (10.8)
            Skin/soft tissue source11 (8.7)9 (10.1)2 (5.4)
            Other source22 (17.5)14 (15.7)8 (21.6)
            Polymicrobial BSI10 (7.9)6 (6.7)4 (10.8)
            Vancomycin-susceptible strainc125 (99.2)88 (98.9)37 (100.0)
            Daptomycin-susceptible strainc,d116 (96.7)80 (96.4)36 (97.3)
            Ceftaroline-susceptible straine94 (96.9)70 (95.9)24 (100.0)
    Treatment information
        No. (%) of patients with:
            Infectious diseases consultf113 (93.4)79 (91.9)34 (97.1)
            Source control pursuedg42 (34.7)28 (32.9)14 (38.9)
            Prior directed therapy with vancomycin107 (84.9)74 (83.1)33 (89.2)
            Prior directed therapy with daptomycin48 (38.1)22 (24.7)26 (70.3)
            Ceftaroline dosing frequency
                Every 8 h66 (52.4)52 (58.4)14 (37.8)
                Every 12 h54 (42.9)33 (37.1)21 (56.8)
                Every 24 h6 (4.8)4 (4.5)2 (5.4)
            Ceftaroline dose
                600 mg76 (60.3)55 (61.8)21 (56.8)
                400 mg19 (15.1)14 (15.7)5 (13.5)
                300 mg11 (8.7)8 (9.0)3 (8.1)
                200 mg20 (15.9)12 (13.5)8 (21.6)
        Median ceftaroline inpatient duration (days) (IQR)13 (5–21)13 (5–22)14 (4–17)
        No. (%) of patients receiving combination therapy with:
            Daptomycin28 (22.2) 28 (75.7)
            Vancomycin3 (2.4) 3 (8.1)
            Gentamicin3 (2.4) 3 (8.1)
            Rifampin5 (4.0) 5 (13.5)
    Outcomes
        No. of patients achieving clinical success (%)86 (68.3)62 (69.7)24 (64.9)
        No. of patients with in-hospital mortality (%)28 (22.2)17 (19.1)11 (29.7)
        No. of patients with cleared BSI on ceftaroline (%)115 (91.3)79 (88.8)36 (97.3)
        Median BSI duration post-ceftaroline initiation (days) (IQR)3 (1–4)2 (1–4)3 (1.5–5)
        Median length of stay post-ceftaroline initiation (days) (IQR)12 (8–20)12 (8–18)15 (8.5–22.5)
    • ↵a Defined as an absolute neutrophil count of <500 cells/mm3 at ceftaroline initiation.

    • ↵b At the time of the index culture.

    • ↵c Susceptibility determined by Microscan, Vitek 2, BD Phoenix, or Etest.

    • ↵d Daptomycin susceptibility were available for 120, 83, and 37 patients in the efficacy population and the monotherapy and combination therapy subgroups, respectively.

    • ↵e Ceftaroline susceptibility was determined by Etest for 97, 73, and 24 patients in the efficacy population and the monotherapy and combination therapy subgroups, respectively.

    • ↵f Infectious diseases consult status known for 121, 86, and 35 patients in the efficacy population and the monotherapy and combination therapy subgroups, respectively.

    • ↵g Pursuit of source control known for 121, 85, and 36 patients in the efficacy population and the monotherapy and combination therapy subgroups, respectively.

  • TABLE 2

    Multivariable logistic regression analysis of factors independently associated with treatment failure with ceftaroline in the efficacy populationa

    VariableOdds ratio (95% CI)Adjusted odds ratio (95% CI)
    APACHE II score1.100 (1.037–1.166)1.093 (1.044–1.145)
    Malignancy6.000 (1.111–32.405)3.127 (1.009–9.686)
    Lower respiratory tract source2.632 (1.198–5.783)
    Bone/joint source0.442 (0.153–1.274)
    Ceftaroline dose
        600 mg
        400 mg3.856 (1.350–11.017)
        300 mg2.892 (0.785–10.651)
        200 mg2.314 (0.814–6.577)
    • ↵a P = 0.574 as determined by a Hosmer-Lemeshow goodness-of-fit test and a variance inflation factor of <3 for all variables included for model entry. CI, confidence interval.

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Multicenter Observational Study of Ceftaroline Fosamil for Methicillin-Resistant Staphylococcus aureus Bloodstream Infections
Evan J. Zasowski, Trang D. Trinh, Kimberly C. Claeys, Anthony M. Casapao, Noor Sabagha, Abdalhamid M. Lagnf, Kenneth P. Klinker, Susan L. Davis, Michael J. Rybak
Antimicrobial Agents and Chemotherapy Jan 2017, 61 (2) e02015-16; DOI: 10.1128/AAC.02015-16

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Multicenter Observational Study of Ceftaroline Fosamil for Methicillin-Resistant Staphylococcus aureus Bloodstream Infections
Evan J. Zasowski, Trang D. Trinh, Kimberly C. Claeys, Anthony M. Casapao, Noor Sabagha, Abdalhamid M. Lagnf, Kenneth P. Klinker, Susan L. Davis, Michael J. Rybak
Antimicrobial Agents and Chemotherapy Jan 2017, 61 (2) e02015-16; DOI: 10.1128/AAC.02015-16
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    • ABSTRACT
    • INTRODUCTION
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KEYWORDS

bacteremia
cephalosporins
endocarditis
methicillin-resistant Staphylococcus aureus
MRSA
bacteremia
treatment failure
infective endocarditis
pneumonia
bone and joint infection
beta-lactam
vancomycin
daptomycin

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