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

Abstract

Ceftaroline is a novel cephalosporin recently approved in children for treatment of acute bacterial skin and soft tissue infections and community-acquired bacterial pneumonia (CABP) caused by methicillin-resistant Staphylococcus aureus, Streptococcus pneumoniae and other susceptible bacteria. With a favorable tolerability profile and efficacy proven in pediatric patients and excellent in vitro activity against resistant Gram-positive and Gram-negative bacteria, ceftaroline may serve as a therapeutic option for polymicrobial infections, CABP caused by penicillin- and ceftriaxone-resistant S. pneumoniae and resistant Gram-positive infections that fail first-line antimicrobial agents. However, limited data are available on tolerability in neonates and infants younger than 2 months of age, and on pharmacokinetic characteristics in children with chronic medical conditions and those with invasive, complicated infections. In this review, the microbiological profile of ceftaroline, its mechanism of action, and pharmacokinetic profile will be presented. Additionally, clinical evidence for use in pediatric patients and proposed place in therapy is discussed.

Eficacia y seguridad de ceftarolina fosamil en niños: revisión sistemática y metaanálisis

“…La vancomicina sigue siendo la primera opción de tratamiento en pacientes con infecciones invasivas por SAMR, pero su toxicidad renal, s u r e d u c i d o e s p e c t r o y l a b a j a concentración que alcanza a nivel tisular justificarían la búsqueda de nuevas alternativas de tratamiento. [1][2][3][4][5] E n 2 0 1 1 , l a S o c i e d a d d e Enfermedades Infecciosas de América recomendó dosis de vancomicina de 15 mg/kg por dosis cada 6 horas p a r a l o s n i ñ o s c o n i n f e c c i o n e s invasivas debidas al SAMR con el objetivo de alcanzar altos niveles de concentración en valle. 1 Esto permitiría que se estableciera un área de vancomicina bajo la curva, que, en los adultos, predecía mejor la eficacia, pero, después de la incorporación de estas recomendaciones, varios autores informaron que, en los pacientes pediátricos, se evidenciaba una asociación entre las dosis mayores de vancomicina y la falla renal.…”

“…2,3 La ceftarolina fosamil es una cefalosporina que ha generado mucho interés como una posible opción de tratamiento. Como es el caso de otras cefalosporinas, la actividad antibacteriana de la ceftarolina es el resultado de la unión a proteínas esenciales que inhibe la síntesis de la [4][5][6][7][8] En Argentina, está aprobado por la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), pero el prospecto autorizado destaca que no debe utilizarse en niños y adolescentes, ya que no existen datos suficientes en estas poblaciones.…”

Safety and effectiveness of ceftaroline fosamil in children: a systematic review and meta-analysis

“…Vancomycin is still the first-line option for patients with invasive MRSA infections, but its kidney toxicity, its narrow spectrum, and its low tissue level would warrant the search for new therapy options. [1][2][3][4][5] In 2011, the Infectious Diseases Society of America recommended vancomycin in doses of 15 mg/kg every 6 hours for children with invasive MRSA infections in order to reach high trough levels. 1 This would allow to establish a vancomycin area under the curve that, in adults, would better predict effectiveness; however, after these recommendations were i m p l e m e n t e d , s e v e r a l a u t h o r s reported that, in pediatric patients, there was an association between higher vancomycin doses and kidney failure.…”

“…Ceftaroline has a broad spectrum of activity against clinically relevant Gram-positive strains, including MRSA and resistant Streptococcus pneumoniae strains, as well as Gram-negative pathogens implicated in skin and soft tissue infections (SSTIs) or communityacquired pneumonia (CAP). [4][5][6][7][8] In Argentina, it was approved by the National Drug, Food and Technology Administration of Argentina (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT), although the authorized package insert indicates that it should not be used in children and adolescents because there are not sufficient data in these populations.…”

Efficacy and safety of ceftaroline: systematic review and meta-analysis

“… 1 – 3 In addition, the drug has been approved by the FDA for CAP caused by Streptococcus pneumoniae , methicillin-sensitive, Staphylococcus aureus (non-MRSA), Escherichia coli, Haemophilus influenzae, Klebsiella pneumonia , and Klebsiella oxytoca . 1 , 3 – 5 Nevertheless, data on the clinical use of ceftaroline are scarce, especially in the pediatric population. 5 …”