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Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and Its Application

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Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and Its Application Infect Dis Ther (2017) 6:57–67 DOI 10.1007/s40121-016-0144-8 REVIEW Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and its Application Juwon Yim . Leah M. Molloy . Jason G. Newland Received: November 10, 2016 / Published online: December 30, 2016 Ó The Author(s) 2016. This article is published with open access at Springerlink.com ABSTRACT infections, CABP caused by penicillin- and ceftriaxone-resistant S. pneumoniae and Ceftaroline is a novel cephalosporin recently resistant Gram-positive infections that fail approved in children for treatment of acute first-line antimicrobial agents. However, bacterial skin and soft tissue infections and limited data are available on tolerability in community-acquired bacterial pneumonia neonates and infants younger than 2 months (CABP) caused by methicillin-resistant of age, and on pharmacokinetic characteristics Staphylococcus aureus, Streptococcus pneumoniae in children with chronic medical conditions and other susceptible bacteria. With a favorable and those with invasive, complicated tolerability profile and efficacy proven in infections. In this review, the microbiological pediatric patients and excellent in vitro profile of ceftaroline, its mechanism of action, activity against resistant Gram-positive and and pharmacokinetic profile will be presented. Gram-negative bacteria, ceftaroline may serve Additionally, clinical evidence for use in as a therapeutic option for polymicrobial pediatric patients and proposed place in therapy is discussed. Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ 1F47F0601BB3F2DD. Keywords: Antibiotic resistance; Ceftaroline J. Yim (&) fosamil; Children; Methicillin-resistant St. John Hospital and Medical Center, Detroit, MI, Staphylococcus aureus; Streptococcus pneumoniae USA e-mail: [email protected] L. M. Molloy INTRODUCTION Children’s Hospital of Michigan, Detroit, MI, USA Antibiotic resistance in Gram-positive bacteria is J. G. Newland St. Louis Children’s Hospital, St. Louis, MO, USA steadily increasing, posing a growing health concern worldwide [1, 2]. Likewise, antibiotic J. G. Newland Washington University School of Medicine, treatment failures have been reported among St. Louis, MO, USA 58 Infect Dis Ther (2017) 6:57–67 children with invasive infections caused by in vitro bactericidal activity against MRSA resistant Gram-positive bacteria [3, 4]. [9, 10]. It is also active against other bacteria Management of these infections in pediatric common in childhood infections, such as S. patients may be even more challenging due to pneumoniae, S. pyogenes, Haemophilus influenzae limited therapeutic options. Antibiotics approved and Moraxella catarrhalis [11]. by the US Food and Drug Administration (FDA) Ceftaroline, like other b-lactams, exerts for treatment of infections caused by bactericidal effects by binding to methicillin-resistant Staphylococcus penicillin-binding proteins (PBPs) to inhibit aureus (MRSA) in children are limited to cell wall synthesis [12]. Ceftaroline is vancomycin, clindamycin and linezolid [5]. distinguished from other b-lactams by its Daptomycin has been increasingly used in enhanced affinity for mutated PBPs that pediatrics despite the lack of safety and efficacy render other b-lactams ineffective against S. data [6]. Finally, for newer antibiotics such as aureus and S. pneumoniae [13]. In S. aureus, the telavancin, dalbavancin and oritavancin, the lack mecA gene-encoded mutant PBP2a confers of pharmacokinetic and clinical studies severely methicillin resistance while b-lactam resistance restricts their use in pediatric infections [7]. in S. pneumoniae results from modification in Ceftaroline is a new cephalosporin with an PBP1A, PBP2X, and PBP2B [14, 15]. Unlike other FDA-approved indications for acute bacterial b-lactams, ceftaroline has unique greater skin and skin structure infections (ABSSI) affinity for these altered PBPs by which it caused by MRSA and community-acquired retains activity against MRSA and bacterial pneumonia (CABP) caused by penicillin-resistant S. pneumoniae. Additionally, Streptococcus pneumoniae and other susceptible ceftaroline has activity against commonly bacteria in children 2 months of age and older encountered Gram-negative bacteria in [8]. In this review, the microbiological profile of children including H. influenzae, Klebsiella ceftaroline, its mechanism of action, and species and Escherichia coli. However, it does pharmacokinetic characteristics will be not have activity against Gram-negative presented. Additionally, clinical evidence for bacteria producing extended-spectrum use in pediatric patients will be discussed. b-lactamase (ESBL) or carbapenemase [16]. In international surveillance studies with clinical isolates, ceftaroline MIC for MSSA Compliance with Ethics Guidelines 90 and MRSA were 0.25–0.5 mg/L and 1–2 mg/L, respectively. Even though ceftaroline MICs for The analysis in this article is based on MRSA isolates were four-fold higher than MSSA previously conducted studies, and does not isolates, a majority of S. aureus isolates were involve any new studies of human or animal susceptible to ceftaroline. Of note, ceftaroline subjects performed by any of the authors. retained activity against heterogeneous vancomycin-intermediate S. aureus, with MICs Antimicrobial Activity and Pharmacology ranging from 0.25 to 4 mg/L [16, 17]. of Ceftaroline Ceftaroline additionally exhibits excellent activity against S. pneumoniae isolates Ceftaroline is known as a novel regardless of its susceptibility to other ‘‘fifth-generation cephalosporin’’ that exhibits antimicrobials, with MIC90 of B0.016 and Infect Dis Ther (2017) 6:57–67 59 0.25 mg/L for penicillin-susceptible and protein binding of ceftaroline is low, estimated penicillin-resistant S. pneumoniae isolates, at *20% [8]. Ceftaroline is not substrate, respectively [16]. Furthermore, it demonstrates inducer or inhibitor of any major CYP significant activity against isoenzymes, minimizing potential for cephalosporin-resistant S. pneumoniae strains, drug–drug interactions [26]. Ceftaroline and its supporting its role in treatment of multi-drug metabolites are eliminated mainly by the resistant S. pneumoniae infections [18]. kidneys, necessitating dose adjustment for Another potentially important renally impaired patients with creatinine pharmacological characteristic is the low clearances of B50 mL/min [8, 27]. propensity of Gram-positive pathogens to The pharmacodynamic (PD) parameter most develop resistance to ceftaroline. Mutant predictive of efficacy is the percentage of the selection did not occur in Gram-positive dosing interval during which serum-free bacteria evaluated in vitro, including S. aureus ceftaroline concentration remains above the and S. pneumoniae after repeated exposure to MIC (%fT [ MIC). In a study using murine ceftaroline [19, 20]. However, clinical thigh and lung infection models, the average implication of the in vitro finding is not yet %fT[MIC needed for bacteriostasis was fully understood, and the emergence of 26 ± 8% for S. aureus and 39 ± 9% for S. resistance to ceftaroline during a course of pneumoniae [28]. A Monte Carlo simulation of therapy has been reported, even though ceftaroline 600 mg every 12 h given to healthy extremely rare [21, 22]. Currently, prevalence adults predicted fT[MIC of 71% and 51% for of ceftaroline-resistant organisms appears to be organisms with MICs of 1 and 2 mg/L, fairly rare in surveillance studies conducted in respectively. Probability of target attainment the United States, with 97.6% MRSA strains and of 40% fT[MIC was 100% at an MIC of 1 mg/L 100% S. pneumoniae strains being susceptible to and 90% at an MIC of 2 mg/L [29, 30]. ceftaroline [23, 24]. In pediatric patients, approved ceftaroline dosing regimens are 8 mg/kg every 8 h in Pharmacokinetics children from 2 months to \2 years of age. In children and adolescents aged 2 years and older, Basic pharmacokinetic parameters known to ceftaroline 12 mg/kg every 8 h is recommended date are based on adult studies. Ceftaroline is for patients weighing B33 kg, and 400 mg every administered as a water-soluble prodrug, 8 h or 600 mg every 12 h for those weighing ceftaroline fosamil, which is rapidly [33 kg. In population PK modeling and metabolized by a phosphatase enzyme to simulations by Riccobene et al. [31], these bioactive ceftaroline and later hydrolyzed to regimens were predicted to produce ceftaroline microbiologically inactive metabolite exposure in children similar to that in adults ceftaroline M-1 [25]. It yields treated with ceftaroline 600 mg every 12 h. The dose-proportional increases in maximum modeled dose regimens attained 36% fT[MIC plasma concentration (Cmax) and area under (median %fT[MIC associated with 1-log kill of the curve (AUC) after administration of single S. aureus) at a MIC of 2 mg/L in [90% of doses of 50–1000 mg. Repeated administration children and 44% fT[MIC (median of ceftaroline for 14 days appears to result in no %fT[MIC associated with 1-log kill of S. appreciable accumulation of the drug. Average pneumoniae) at MIC of 1 mg/L in 97% of 60 Infect Dis Ther (2017) 6:57–67 children [31]. With MIC90 of 1 mg/L and Clinical Efficacy and Safety 0.12 mg/L for MRSA and S. pneumoniae in the US, respectively [17, 24], currently approved FDA-Labeled Indications dosing regimens are predicted to maintain In May 2016, the FDA approved ceftaroline for adequate PD target in a majority of pediatric the treatment of ABSSI and CABP among patients. Of interest, ceftaroline
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