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Drugs Ceftaroline Fosamil in the Treatment of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infections Lodise T and Low DE

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Table S1. In vitro and in vivo efficacy models involving ceftaroline fosamil

Model Pathogen Regimen Major findings

In vitro hollow-fiber

3-day treatment

Vidaillac et al.[31]

MRSA R4039

MRSA R5200

MRSA R3804

MRSA 494

hVISA R1629

hVISA Mu3

Ceftaroline fosamil 600 mg

q12h (simulated)

Time (h) at which

bactericidal effect (≥3 log

kill) was achieved:

6.5

6.8

26.8

12

28.3 – 35 (transient)

5.05 – 44

In vitro hollow-fiber

4-day treatment

Steed et al.[30]

MRSA R5717

MRSA R5563

hVISA R5996

VISA R5995


q12h (human-simulated)

Change from baseline in

bacterial burden (log10

CFU/g):

-3.1

-2.5

-5.77

-6.38

Table S1. (continued). In vitro and in vivo efficacy models involving ceftaroline fosamil Model Pathogen Regimen Major findings

In vitro PD model

24-hour treatment

Zhanel et al.[32]

MSSA 89608

MSSA 89637

CA-MRSA 84771

HA-MRSA 84495

hVISA 86775

VISA NRS18

VISA NRS21

VISA NRS4

VRSA VRS1

VRSA VRS3a



Change in bacterial

burden (mean ± SD

log10 CFU/g) relative

to initial inoculum

after 12 hours:

-3.7 ± 0.7

-3.9 ± 0.6

-3.6 ± 0.7

-3.2 ± 0.4

-3.2 ± 0.6

-3.2 ± 0.5

-3.3 ± 0.8

-3.1 ± 0.7

-3.1 ± 0.5

-3.1 ± 0.6


Mouse thigh

infection

model

24-hour

treatment

Keel et al.[29]

MRSA (n=22) and

MSSA (n=4)

MRSA (n=13)



Neutropenic

Immunocompetent



CFU/g):

-0.95 to -3.28

-1.06 to -2.43

Mouse thigh

infection

model

24-hour

treatment

Housman et

al.[33]

Enterobacteriaceae

(n=35; with

ceftaroline MICs

from 0.25 to 32

mg/L)



Neutropenic

MIC ≤ 1 mg/L

MIC = 2 mg/L

MIC ≥ 4 mg/L



CFU/g):

-0.65 to -2.36 (18/20

isolates)

-0.67 to 1.91 (5/7

isolates)

Limited efficacy reported


Rabbit endocarditis

4-day treatment

Jacqueline et

al.[34]

MRSA

hGISA

Control

Ceftaroline 10 mg/kg/12ha

Linezolid 10 mg/kg/12ha

Vancomycin steady state 20x

MICa

Control




MICa

Bacterial burden at end

of study (mean ± SD

log10 CFU/g):

8.9 ± 0.5

2.5 ± 0.3

7.1 ± 0.6

2.7 ± 0.8

9.4 ± 0.3

3.0 ± 0.9

6.9 ± 0.4

6.7 ± 0.4


Rabbit endocarditis

4-day treatment

Jacqueline et al.[35]

MSSA

MRSA

GISA

Control


Daptomycin 6 mg/kg/24ha

Tigecycline 50 mg/kg/24h

Control




Control






log10 CFU/g):

9.63 ± 0.80

≤2.44 ± 0.27

3.85 ± 2.43

6.89 ± 1.83

8.80 ± 0.33

≤2.59 ± 0.12

3.52 ± 1.98

7.11 ± 1.18

8.51 ± 0.39

≤2.48 ± 0.12

≤2.57 ± 0.31

7.20 ± 1.27


Rabbit endocarditis

4-day treatment


E. faecalis

(vancomycin-

susceptible)

E. faecalis

(vancomycin-

resistant)

Control




MICa

Control




MIC



log10 CFU/g):

8.57 ± 0.74

5.68 ± 0.49

6.88 ± 0.70

6.70 ± 0.25

8.60 ± 0.54

3.98 ± 0.85

6.88 ± 0.77

8.01 ± 0.76


Rabbit acute

osteomyelitisa

4-day treatment


MRSA

GISA

Controls


Linezolid 10 mg/kg/12h


MIC

Controls




MIC

Change in bacterial

burden (mean ± SD

log10 CFU/g ) in bone

after treatment:

0.11 ± 0.81

-2.83 ± 1.50

-2.25 ± 1.55

-0.52 ± 0.69

0.23 ± 0.41

-2.01 ± 0.90

-2.23 ± 1.08

-0.57 ± 0.44


Rabbit pneumonia

2-day treatment

Croisier-Bertin et

al.[38]

CRO-S

PSSP

CRO-S PISP

CRO-R

PRSP

Controls

Ceftaroline 10 mg/kg/12h

(HE)a

Ceftriaxone 1 g/24h (HE)a

Controls


(HE)a

Ceftriaxone 1 g/24h (HE)a

Controls


(HE)a

Ceftriaxone 1 g/24h (HE)

Bacterial burden in lung

(mean log10 CFU/g,

approximated from

graph) at end of study:

8.0

1.0

1.0

8.0

1.0

1.0

8.0

1.0

6.0


Rabbit meningitis

Cottagnoud et

al.[39]

PSSP

PRSP

Controls

Ceftaroline 40 mg/kg at 0 and

4 h

Ceftriaxone 100 mg/kg

Controls


4 h

Ceftriaxone 100 mg/kg +

Vancomycin 20 mg/kg at 0

and 4 h

Change in bacterial

burden (mean ± SD

log10 CFU/g) after 8 h:

1.23 ± 0.33

-6.35 ± 0.47

-5.54 ± 0.98

0.95 ± 0.47

-5.54 ± 0.61

-4.65 ± 1.00

Rabbit meningitis

Cottagnoud et

al.[40]

K.

pneumoniae

Controls


4 h

Cefepime 100 mg/kg at 0 and

4 h

Change in bacterial

burden (mean ± SD

log10 CFU/g) after 8 h:

1.08 ± 0.22

-5.61 ± 1.08

-3.54 ± 0.94

aP<0.001 versus controls.

CA-MRSA = community-associated methicillin-resistant S. aureus; CFU = colony-forming unit;

CRO-R = ceftriaxone-resistant; CRO-S = ceftriaxone-susceptible; GISA = glycopeptide-

intermediate S. aureus; HA-MRSA = healthcare-associated methicillin-resistant

S. aureus; HE = human equivalent; hGISA = heteroresistant glycopeptide-intermediate S.

aureus; hVISA = heteroresistant vancomycin-intermediate S. aureus; MIC = minimum inhibitory

concentration; MRSA = methicillin-resistant S. aureus; MSSA = methicillin-susceptible S.

aureus; PD = pharmacodynamics; PISP = penicillin-intermediate S. pneumoniae; PRSP =

penicillin-resistant S. pneumoniae; PSSP = penicillin-susceptible S. pneumoniae; SD = standard

deviation; VISA = vancomycin-intermediate S. aureus; VRSA = vancomycin-resistant S. aureus.

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