C L I N I C A L F E AT U R E S

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Ceftaroline Fosamil for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Obese Patients

DOI: 10.3810/pgm.2014.09.2807

John D. Evans, PharmD, MBA 1 George Udeani, PharmD, DSc 2 Phillip Cole, MD 3 H. David Friedland, MD, MBA 4 Director of Pharmacy Services, CHRISTUS Spohn Hospital–Alice, Alice, TX; 2Clinical Specialist– Pharmacy, CHRISTUS Spohn Hospital–Shoreline, Corpus Christi, TX; 3Associate Director, Clinical Development, Cerexa, Inc., Oakland, CA; 4Vice President, Clinical Development, Cerexa, Inc., Oakland, CA 1

Abstract

Background: Ceftaroline fosamil is a broad-spectrum antibiotic approved by the US Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia. The Clinical Assessment Program and Teflaro Utilization Registry (CAPTURE) is a multicenter registry study of patients treated with ceftaroline fosamil in the United States for ABSSSI or community-acquired bacterial pneumonia. Objective: To describe the clinical effectiveness of ceftaroline fosamil in the treatment of ABSSSI in obese patients [body mass index (BMI) $ 30] compared with patients with a normal BMI (18.5 to # 24.9). Methods: Data were collected at US study centers by randomly ordered chart review. Results: Data from 261 patients with a normal BMI and 690 patients with an obese BMI were collected. The percentage of males was higher in the normal BMI than in the obese category (58.2% and 49.0%, respectively). The mean and median ages at baseline were similar. Most patients (91%) were treated on a general hospital ward, and the mean and median lengths of stay were similar between the 2 groups (approximately 11 days and 7 days, respectively). A total of 73.2% of normal BMI patients and 77.5% of obese patients were discharged to home. Rates of diabetes mellitus were 26.4% in the normal BMI group and 55.1% in the obese group. Methicillin-resistant Staphylococcus aureus was isolated from 26.1% of normal BMI patients and 20.5% of obese patients (16.4% morbidly obese subset). Mean treatment duration for all patients was 5.9 days. Of patients with a normal BMI, 57.5% received ceftaroline fosamil as monotherapy as did 63.3% of obese patients. Clinical success was high in both the normal BMI (85.1%) and the obese (89.0%) groups. Conclusion: Ceftaroline fosamil is an effective treatment option for obese patients with ABSSSI with a similar clinical success rate, mean and median length of stay, and discharge destination to home when compared with normal BMI patients. Keywords: ceftaroline fosamil; obesity; ABSSSI; Staphylococcus aureus; CAPTURE

Introduction

Correspondence: John D. Evans, PharmD, MBA, 4476 FM 666, Robstown, TX 78380. Tel: 432-889-7122 Email: [email protected]

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Obesity is an increasing problem globally, and obese patients are at increased risk of developing infections.1,2 The recovery of methicillin-resistant Staphylococcus aureus (MRSA) from cellulitis has been shown to be significantly associated with obesity, and obesity is a risk factor for antibiotic treatment failures.3,4 In addition, obese patients frequently have underlying comorbidities such as diabetes mellitus and peripheral vascular disease. The use of antibiotics in obese patients may be further complicated by the need for the dosage adjustment of antibiotics where weight

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Ceftaroline Fosamil: Treatment of ABSSSI in Obese Patients

is a crucial variable, such as in the case of vancomycin or daptomycin.5 Ceftaroline fosamil, the prodrug of ceftaroline, is a cephalosporin antibiotic approved by the US Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and communityacquired bacterial pneumonia and by the European Medicines Agency for similar indications. Ceftaroline has broad-spectrum in vitro activity, which includes gram-positive bacteria such as S. aureus and Streptococcus pneumoniae, including their resistant phenotypes of MRSA and multidrugresistant S. pneumoniae. In addition, ceftaroline has in vitro activity against common gram-negative bacteria such as Haemophilus influenzae (including β-lactamase–positive strains), Escherichia coli, and Klebsiella pneumoniae.6,7 As with other cephalosporins it is not active against Enterobacteriaceae that produce extended-spectrum β-lactamases or against AmpC-overexpressing strains.6 Ceftaroline is bactericidal in vitro and, as with other β-lactams, acts by targeting bacterial penicillin-binding proteins. Unlike other β-lactams, ceftaroline binds with high affinity to penicillin-binding protein-2a in MRSA because of its unique chemical structure. The Clinical Assessment Program and Teflaro Utilization Registry (CAPTURE) is a registry study designed to collect information on the contemporary clinical use of ceftaroline fosamil in the United States for ABSSSI and communityacquired bacterial pneumonia. This article describes the clinical effectiveness of ceftaroline fosamil in the treatment of ABSSSI in obese patients compared with patients with a normal body mass index (BMI).

Materials and Methods Study Design

Patients treated with ceftaroline fosamil were identified through a sequential review of charts that had been randomly ordered from pharmacy lists at participating institutions. Eligible patients were aged $ 18 years with a diagnosis of ABSSSI as defined by an infection involving deeper soft tissue or requiring significant surgical intervention. Data collection began in August 2011. Initially, patients where eligible if they had received $ 2 consecutive doses of ceftaroline fosamil; however, following a protocol amendment in July 2012, this was revised to patients receiving $ 4 consecutive doses. The final dose of ceftaroline fosamil was administered $ 30 days before data collection to ensure completeness of data available in the patient chart. Charts were excluded from patients with additional or underlying infections, except for bacteremia associated with

ABSSSI, and were also excluded if information on dosing with ceftaroline fosamil was missing or if data had been previously extracted for this study. The study was approved by each institution’s ethics committee or institutional review board and was conducted in compliance with the International Conference on Harmonisation E6 Good Clinical Practice guidance.8

Data Collection and Analysis

Data were collected by review of charts from August 2011 to April 2013 on demographics, relevant medical history, bacterial pathogens, location of care, patient discharge destination, and clinical signs and symptoms at the time of diagnosis with ABSSSI and at the end of ceftaroline fosamil treatment. Information on the use of other antibiotics prior to or concurrent with the administration of ceftaroline fosamil and the clinical response to treatment were also collected. A study protocol amendment in July 2012 included additional data collection such as ceftaroline fosamil dosage, dosing frequency, readmission within 30 days of discharge, and reason for readmission. There were 2 study populations: the enrolled population, which contained all patients who met the inclusion criteria and none of the exclusion criteria, for whom chart data had been extracted; and the evaluable population, which contained all enrolled patients who had sufficient information available to determine a clinical response (clinical success or failure). Clinical success was defined as clinical cure with no further need for antibiotic or clinical improvement with switch to oral antibiotic. Clinical response could also be classified as a success if the patient was confirmed to be improving at the time of discontinuation of ceftaroline fosamil with no other evidence of clinical failure. Clinical failure was defined as discontinuation due to an adverse event or insufficient therapeutic effect and switch to another antibiotic. Three patient groups were used in this analysis based on the BMI: normal BMI (18.5 to # 24.9 kg/m2), obese (BMI $ 30 kg/m2), with a morbidly obese subset (BMI $ 40 kg/m2) as defined by the US Centers for Disease Control and Prevention (CDC). Descriptive analyses were performed on the evaluable population for patient demographics and disease characteristics, location of care, lengths of stay and hospital discharge information, bacterial pathogens isolated, ceftaroline fosamil usage including treatment duration and reasons for discontinuation, and prior and concurrent antibiotics received, as well as clinical response. Statistical analyses were performed using SAS Version 9.2.

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Results Patient Baseline Characteristics

Data from 261 evaluable patients with a normal BMI and 690 with a BMI that classified them as obese were collected as part of the CAPTURE study. Among the 690 obese patients 274 (39.7%) were classified as morbidly obese. The percentage of males was higher in the normal BMI category than in the obese (58.2% and 49.0%, respectively) and the mean and median age at baseline were similar across all groups, including the morbidly obese subset (Table 1). The majority of patients (91%), irrespective of BMI, were treated with ceftaroline fosamil in a general hospital ward. The mean and median length of stay were similar across all patient groups (Table 1). The range of length of stay was greater in the obese population (2–304 days) compared with the normal BMI group (2–124 days). This was due to a small number of patients with a longer length of stay: 4 obese patients stayed in hospital for . 100 days compared with 1 patient in the normal BMI group. The destination following discharge for the majority of patients ($ 73.2%) in each group was home, with similar percentages of normal and obese patients discharged to another care facility (23.8% and 21.2%, respectively). For patients with readmission data (data collected in year 2 of the study), between 12.0% and 14.0% were readmitted within 30 days of discharge (Table 1), of which readmission associated with an ABSSSI was 3.7% in the normal BMI group and 5.1% in the obese group.

Infection Characteristics

Deep or extensive cellulitis was the most common type of infection in this study, with approximately two-thirds of patients in each of the 3 BMI groups having this diagnosis (Table 2). The most common site of infection in all groups was the leg/thigh; however, the percentage of patients with infections at this site was higher in the obese group and morbidly obese subset than in the normal BMI group (55.5%, 69.3%, and 34.9%, respectively) (Table 2). The frequency of diabetes mellitus was higher in the obese group and the morbidly obese subset with rates of 55.1% (380/690) and 59.9% (164/274), respectively compared with 26.4% (69/261) in the normal BMI group. Rates of peripheral vascular disease were similar in the 3 groups: 17.5% in both the obese (121/690) and morbidly obese (48/274) groups, and 16.1% (42/261) in the normal BMI group. The frequency of patients with both diabetes mellitus and peripheral vascular disease was higher among obese patients when compared with normal BMI patients (14.1% [97/690] and 5.4% [14/261], respectively). In the morbidly obese patient subset, 13.9% (38/274) had both diabetes mellitus and peripheral vascular disease. The predominant bacterial pathogen isolated in both the obese and normal weight populations was S. aureus. MRSA was isolated from 26.1% (68/261) of normal BMI patients and methicillin-sensitive S. aureus (MSSA) from 9.2% (24/261). In the obese population, 20.6% (142/690)

Table 1.  Patient Characteristics and Disposition of Patients by BMI Groupa

Gender Age at baseline, years Location of care during ceftaroline fosamil administration Length of stay in hospital, daysc Destination following discharged

In hospital mortality Readmission, n (%)e

Male, n (%) Mean (SD) Median (range) General hospital ward, n (%) ICU, n (%) OPAT, n (%) Mean (SD) Median (range) Home, n (%) Another care facility, n (%) OPAT unit Overall Associated with ABSSSI

Normal BMI

Obeseb

Morbidly obese

N = 261

N = 690

N = 274

152 (58.2) 59 (20.6) 60 (18–96) 238 (91.2) 15 (5.8) 8 (3.1) 11.2 (12.7) 7.0 (2–124) 191 (73.2) 62 (23.8) 2 (0.8) 6 (2.3) 15 (12.4) 5 (3.7)

338 (49.0) 58 (15.7) 58 (18–96) 634 (91.9) 48 (7.0) 8 (1.2) 10.8 (17.4) 7.0 (2–304) 533 (77.5) 146 (21.2) 7 (1.0) 2 (0.3) 38 (12.0) 18 (5.1)

128 (46.7) 56 (13.3) 58 (25–91) 251 (91.6) 20 (7.3) 3 (1.1) 11.9 (23.4) 8.0 (2–304) 210 (77.2) 59 (21.7) 3 (1.1) 0 (0.0) 17 (14.0) 7 (5.1)

Normal BMI: 18.5 to # 24.9 kg/m2; obese BMI: $ 30 kg/m2; morbidly obese BMI: $ 40 kg/m2. Includes morbidly obese patients. c N values for duration of stay in hospital are as follows: normal BMI, 253; obese, 682; morbidly obese, 271. d Data missing for 2 patients in the obese group (categorized as morbidly obese). e Readmission data only available for year 2 of the study; therefore, n values are normal BMI, 121; obese, 317; morbidly obese, 121. Abbreviations: ABSSSI, acute bacterial skin and skin structure infection; BMI, body mass index; ICU, intensive care unit; OPAT: outpatient antibiotic therapy. a

b

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Table 2.  Types and Sites of ABSSSI in Patients With Normal BMI and Obese or Morbidly Obese BMIa Normal BMI

Obeseb

Morbidly obese

N = 261

N = 690

N = 274

Type of infectionc n, %   Deep/extensive cellulitis   Infected ulcer   Infected surgical wound   Major abscess   Skin or skin structure infection in patient with DM or PVD

164 (62.8) 44 (16.9) 29 (11.1) 56 (21.5) 63 (24.1)

443 (64.2) 97 (14.1) 78 (11.3) 111 (16.1) 274 (39.7)

180 (65.7) 39 (14.2) 21 (7.7) 34 (12.4) 123 (44.9)

Site of infectionc, d n, %  Arm/forearm  Buttocks  Foot  Leg/thigh

39 (14.9) 27 (10.3) 52 (19.9) 91 (34.9)

44 (6.4) 37 (5.4) 160 (23.2) 383 (55.5)

15 (5.5) 9 (3.3) 53 (19.3) 190 (69.3)

Normal BMI: 18.5 to # 24.9 kg/m2; obese BMI: $ 30 kg/m2; morbidly obese BMI: $ 40 kg/m2. Obese population also contains the morbidly obese subset data. c More than 1 type or site of infection could be present in a single patient. d Data only presented when have . 10% of patients in any 1 category. Sites not included in the table: abdomen (normal BMI 20 [7.7%], obese 62 [9.0%], morbidly obese 26 [9.5%]), hand (21 [8.1%], 20 [2.9%], 4 [1.5%]), head/neck (25 [9.6%], 33 [4.8%], 7 [2.6%]). Abbreviations: ABSSSI, acute bacterial skin and skin structure infections; BMI, body mass index; DM: diabetes mellitus; PVD: peripheral vascular disease. a

b

of patients had MRSA and 10.9% (75/690) had MSSA. In the morbidly obese subset, 16.4% (45/274) had MRSA and 8.4% (23/274) had MSSA.

Antibiotic Usage

The mean duration of treatment for patients with normal BMI and obese patients was 5.9 days (Table 3), and a similar percentage of patients in each BMI group received prior antibiotic therapy. More than 97% of patients received ceftaroline fosamil every 12 hours with the remaining small number of normal BMI and obese patients receiving dosing every 8 hours or every 24 hours. The most commonly used prior antibiotic class were glycopeptides (eg, vancomycin) with 38.3% of patients with normal BMI and 46.2% of obese patients receiving a glycopeptide prior to commencing therapy with ceftaroline fosamil. More than half of patients with a normal BMI received ceftaroline fosamil as monotherapy (57.5%) as did two thirds of obese patients (63.3%). The most commonly used concurrent antibiotic class were lincosamides (eg, clindamycin), which were received by 9.2% of normal BMI patients and 12.6% of obese patients. The second most commonly used concurrent antibiotic class was glycopeptides (9.2% and 6.4% in the normal and obese populations, respectively).

Clinical Response

Rates of clinical success were high in both the normal BMI (85.1%) and the obese groups (89.0%; Table 4). The rate of clinical success was similarly high in the morbidly obese subset (87.2%). These rates of clinical success remained

comparable when ceftaroline fosamil was used as first-line therapy, second-line therapy, or as concurrent therapy or monotherapy. A total of 61/690 (8.8%) obese patients, 30/274 (10.9%) morbidly obese patients, and 25/261 (9.6%) patients with a normal BMI were noted to have insufficient therapeutic effect and were switched to alternative antibiotics. For patients who were switched from ceftaroline fosamil either because of clinical improvement (with switch to oral antibiotic) or because of insufficient therapeutic effect (with switch to IV antibiotic), the most common antibiotic class they were switched to were tetracyclines (eg, doxycycline; 19.1% [77/403] of obese patients, 18.8% [27/144] of normal BMI patients). The second most common antibiotic class that patients were switched to were lincosamides (15.1%, 61/403) among the obese patients and penicillins (eg, piperacillin-tazobactam; 13.9%, 20/144) among patients with a normal BMI. Signs and symptoms of ABSSSI on the day of diagnosis and at end of treatment are shown in Figure 1. The incidence of each sign or symptom of ABSSSI at the end of ceftaroline fosamil treatment was less than half the rate at diagnosis. For example, 88.3% of obese patients presented with erythema at diagnosis; this was reduced to 43.5% at the end of treatment with ceftaroline fosamil. A similar reduction in erythema was seen among patients with a normal BMI, from 82.4% to 32.2% at end of treatment.

Safety

A total of 12 adverse events were recorded as a reason for discontinuation of therapy among normal BMI or obese

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Table 3.  Ceftaroline Fosamil Usage and Prior and Concurrent Antibiotics Received in Patients With Normal BMI and Obese BMIa Normal BMI Obese

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Duration of treatment, days   Mean (SD)   Median (range) Dosing frequency, n (%)b   Every 8 hours   Every 12 hours   Every 24 hours Prior antibioticsc   All antibiotics   Glycopeptides (eg, vancomycin)   Penicillins (eg, piperacillin-tazobactam)   Cephalosporins (eg, cefazolin)   Lincosamides (eg, clindamycin) Ceftaroline fosamil monotherapy, n (%) Concurrent antibioticsd   All antibiotics   Lincosamides (eg, clindamycin)

N = 261

N = 690

5.9 (5.0) 4.0 (1–37)

5.9 (4.5) 5.0 (1–64)

1/136 (0.7) 134/136 (98.5) 1/136 (0.7) n (%)

6/358 (1.7) 350/358 (97.8) 2/358 (0.6) n (%)

204 (78.2) 100 (38.3) 57 (21.8) 52 (19.9) 42 (16.1) 150 (57.5)

544 (78.8) 319 (46.2) 182 (26.4) 156 (22.6) 94 (13.6) 437 (63.3)

110 (42.2) 24 (9.2)

252 (36.5) 87 (12.6)

Normal BMI: 18.5 to # 24.9 kg/m2; obese BMI: $ 30 kg/m2. Data on dosing only collected in year 2 of CAPTURE study. c Data only presented when have . 10% of patients in any 1 category. Antibiotics not included in table: quinolones (20 [7.7%] and 44 [6.4%]), oxazolidinones (9 [3.5%], 32 [4.6%]), tetracyclines (10 [3.8%], 25 [3.6%]), macrolides (4 [1.5%], 9 [1.3%]) on normal BMI and obese populations, respectively. d Data only presented when have . 10% of patients in any 1 category. Antibiotics not included in table: glycopeptides (24 [9.2%], 44 [6.4%]), penicillins (8 [3.1%], 32 [4.6%]), cephalosporins (9 [3.5%], 19 [2.8%]), quinolones (15 [5.8%], 17 [2.5%]), oxazolidinones (11 [4.2%], 13 [1.9%]), tetracyclines (8 [3.1%], 6 [0.9%]), macrolides (5 [1.9%], 2 [0.3%]), in the normal BMI and obese populations, respectively. Abbreviation: BMI, body mass index. a

b

patients, with 8 of the 12 in the obese population (2 patients with an adverse event were in the morbidly obese subset). Details of adverse events were reported for 3 patients in the obese population: cardiac arrest (1 patient), pruritus (1 patient), and significant petechial rash of the extremities (1 patient). For the remaining 5 adverse events in the obese population no additional details were recorded. Four adverse events were recorded among patients with a normal BMI. The details of 1 adverse event (1 patient) were recorded as Table 4.  Clinical Success Rates for Patients With Normal BMI and Obese or Morbidly Obese BMIa

Clinical success, n (%) First-line therapy Second-line therapy Concurrent therapy Monotherapy

Normal BMI

Obeseb

Morbidly obese

222/261 (85.1) 48/57 (84.2) 174/204 (85.3) 93/111 (83.8) 129/150 (86.0)

614/690 (89.0) 127/146 (87.0) 487/544 (89.5) 221/253 (87.4) 393/427 (89.9)

239/274 (87.2) 48/61 (78.7) 191/213 (89.7) 89/106 (84.0) 150/169 (89.3)

Normal BMI: 18.5 to # 24.9 kg/m2; obese BMI: $ 30 kg/m2; morbidly obese BMI: $ 40 kg/m2. b Obese population also includes the morbidly obese subset. Abbreviation: BMI, body mass index. a

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myelodysplastic syndrome. No additional details of the other 3 events were recorded.

Discussion

There is a recognized relationship between obesity and ABSSSIs, and infections in the obese population can be problematic to treat.1,9,10 It is vitally important that there are effective treatment options for this group, especially as MRSA is a key pathogen.3 Ceftaroline fosamil is an antibiotic in the cephalosporin class with activity against MRSA, and it may be a viable treatment option for ABSSSI in obese patients. Therefore, we have presented ceftaroline fosamil usage and clinical response data for obese patients as compared with normal BMI patients treated for ABSSSIs in the CAPTURE study. The demographics of the obese and normal BMI groups in this study were similar, with the exception that the normal BMI group had a higher percentage of males. The mean and median duration of stay were also similar; however, the range of length of stay was greater in the obese (and morbidly obese) population due to a small number of outliers. Negligible differences were seen between the 2 groups in discharge destination or readmission rates. The data presented here suggest that treatment with ceftaroline fosamil, in general, is associated with similar lengths of stay and discharge to home for normal and obese patients. Not unexpectedly, cellulitis was the most common type of infection reported in this study, and the leg and thigh, followed by the foot, were the most common sites of infection for all patient groups (although the frequency was higher in the obese group [55.5%] when compared with the normal BMI group [34.9%]). Staphylococcus aureus is a key pathogen and there is concern for the increasing prevalence of community-acquired MRSA.11,12 Staphylococcus aureus was isolated from 35.2% of normal BMI patients and 31.4% of obese patients (24.8% of morbidly obese patients), although the normal BMI group had a higher rate of MRSA than the obese (or morbidly obese) group. The data from this study are different from that of Khawcharoenporn et al,3 who reported an increased rate of MRSA in obese patients, although they also reported that the non-MRSA group in their study had a higher incidence of diabetes. This difference may be explained, in part, by differences in study design. Both diabetes mellitus and peripheral vascular disease are well described comorbidities among obese patients,13,14 and the rate of diabetes was twice as high in obese patients when compared with normal BMI patients in CAPTURE. However, rates of peripheral vascular disease were similar

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Figure 1.  Signs and symptoms on day of diagnosis and at end of treatment with ceftaroline fosamil among patients with a normal (N = 261) BMI and obese or morbidly obese (N = 690) BMI.

Abbreviation: BMI, body mass index.

across the 3 patient groups. The percentage of patients with both diabetes mellitus and peripheral vascular disease was higher in the obese and morbidly obese groups, which demonstrates the complexity of this patient population with multiple significant comorbidities. The duration of treatment was similar in the normal BMI and obese groups (5.9 days), suggesting that although some antibiotics need to be dosed on a weight basis, ceftaroline fosamil is suitable for patients with a range of BMIs. In addition, a similar percentage of patients in each group received prior antibiotics, of which glycopeptides were the most commonly used class. Rates of clinical success were high and similar in the normal BMI and obese groups, as well as the morbidly obese subset. Clinical success was similar when ceftaroline fosamil was used as first-line or second-line therapy, or as concurrent therapy or monotherapy. Clinical success in this study compares favorably with clinical cure rates reported in the phase 3 clinical trials for ceftaroline fosamil in the treatment of ABSSSIs, where rates of 91.6% and 85.9% were reported for the clinically evaluable and modified intent-to-treat populations, respectively.15 The clinical success rates reported in CAPTURE also compare favorably with clinical trial data for other antibiotics. Rates of 87% and 88% were reported for telavancin and vancomycin in the treatment of cellulitis, and in the treatment of cellulitis and erysipelas, daptomycin and

vancomycin clinical success rates were 94.0% and 90.2%, respectively.16,17

Limitations

The CAPTURE study has limitations that are inherent to a retrospective registry study, including potential variability in reporting given nonstandardized patient charts as source documentation and the lack of a randomized study design with a comparator group. Despite these limitations, registry studies are valuable tools in collecting information on the contemporary use of antibiotics and their effectiveness in clinical practice.18

Conclusion

Ceftaroline fosamil is an effective treatment option for obese patients with ABSSSI with similar clinical success rates, mean and median length of stay, and discharge destination when compared with normal weight patients. Obesity is increasing in prevalence, and obese patients can be challenging to treat due to the presence of multiple significant comorbidities. Further studies are warranted in the area of obesity and ABSSSIs to better serve this growing patient population.

Acknowledgments

We thank the participating investigators and their staff for their contribution to this study. CAPTURE is funded

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by Cerexa, Inc., a wholly owned subsidiary of Forest Laboratories, LLC. Micron Research Ltd. assisted in the preparation of the manuscript. This assistance was funded by Forest Laboratories, LLC.

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Conflict of Interest Statement

John D. Evans, PharmD, MBA, and George Udeani, PharmD, DSc, are investigators for CAPTURE. Phillip Cole, MD, and H. David Friedland, MD, MBA, are employees of Cerexa, Inc., a wholly owned subsidiary of Forest Laboratories, LLC. Phillip Cole, MD, and H. David Friedland, MD, MBA are also shareholders in Actavis plc, which acquired Forest Laboratories in July 2014.

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Ceftaroline fosamil for the treatment of acute bacterial skin and skin structure infections in obese patients.

Ceftaroline fosamil is a broad-spectrum antibiotic approved by the US Food and Drug Administration (FDA) for the treatment of acute bacterial skin and...
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