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Ceftaroline and Ceftaroline–Avibactam
Published in M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson, Kucers’ The Use of Antibiotics, 2017
Ceftaroline is administered intravenously. In a phase II study of patients with complicated skin and skin structure infections (cSSSIs), ceftaroline 600 mg twice daily was administered in adults (Talbot et al., 2007). For S. pneumoniae respiratory tract infection, ceftaroline 600 mg twice daily should be adequate from a pharmacodynamic standpoint, when the ceftaroline MIC is ≤ 1 μg/ml (Van Bambeke et al., 2007).
Treatment options for neonatal infections in the post-cefotaxime era
Published in Expert Review of Anti-infective Therapy, 2022
Susannah Franco, Daniel Rampersad, Daniel Mesa, Margaret R. Hammerschlag
Ceftazidime lacks Gram-positive coverage and cannot replace cefotaxime for presumptive management of neonatal sepsis or meningitis [9,11]. Data including extremely preterm neonates show comparable safety profiles between ceftazidime and cefepime despite cefepime’s lack of FDA approval in neonates [9]. Cefepime should be considered for use over ceftazidime in neonates within institutions without access to cefotaxime, but additional studies are needed to adequately assess the therapeutic potential of cefepime in preterm and VLBW neonates. Ceftaroline cannot currently be recommended due to poor CSF penetration data and a lack of neonatal data overall. More data are needed to optimize neonatal dosing and guide appropriate use of all cephalosporins for neonatal infections. When cefotaxime ultimately becomes permanently unavailable in the U.S., every neonatal provider will need to be prepared to consider the differences in spectrum, resistance, and CSF penetration of these agents for each neonate with suspected sepsis or meningitis.
Emerging antibiotics for community-acquired pneumonia
Published in Expert Opinion on Emerging Drugs, 2019
Adamantia Liapikou, Catia Cilloniz, Andrea Palomeque, Toni Torres
The approval of ceftaroline for the treatment of CAP was based on two phase III multinational RCTs conducted in hospitalized patients: FOCUS 1 (NCT00621504) and FOCUS 2 (NCT00509106). In these, 600 mg ceftaroline fosamil was given every 12 h and demonstrated noninferiority to 1 g ceftriaxone every 24 h, but with differences in clinical cure rates at the test-of-cure visit favoring ceftaroline fosamil in each trial [40,41]. With ceftaroline, clinical cure was achieved in up to 80% of cases and the agent was well tolerated, with only mild adverse events (e.g., diarrhea, headache, and insomnia). However, neither study included patients admitted to intensive care or who had comorbidities, and there were few MDR S. pneumoniae (n ≤ 10) and MRSA (n = 1) isolates. Analysis of data from the FOCUS trials showed that ceftaroline was still associated with a shorter time to clinical response than ceftriaxone [42]. Although there are no data from RCTs supporting the use of ceftaroline fosamil for MRSA pneumonia, some research supports its efficacy in cases of MRSA bacteremia, MRSA endocarditis, and CAP [43,44].
Antibiotic use for community-acquired pneumonia in neonates and children: WHO evidence review
Published in Paediatrics and International Child Health, 2018
Shrey Mathur, Aline Fuchs, Julia Bielicki, Johannes Van Den Anker, Mike Sharland
Ceftaroline fosamil is a broadspectrum cephalosporin antibiotic with activity against many bacteria, including S. pneumoniae (both penicillin-non-susceptible and multi-drug-resistant strains) and S. aureus (including methicillin-resistant S. aureus) [23]. In a phase 2/3 study (NCT01530763), 160 paediatric patients hospitalised with CAP received either intravenous ceftaroline fosamil or ceftriaxone in a randomised, active-controlled, observer-blinded clinical trial. The effectiveness of ceftaroline fosamil was similar to that of ceftriaxone, with high clinical cure rates at test of cure in the modified intention-to-treat population (94/107; 88% and 32/36; 89%, respectively). Three documented S. aureus infections were successfully treated in the ceftaroline group, including one caused by methicillin-resistant S. aureus. In the phase 4 study (NCT01669980), the safety and effectiveness of ceftaroline fosamil in children was evaluated in a multi-centre, randomised, observer-blinded, active-controlled trial[24]. Ceftaroline fosamil was compared with intravenous ceftriaxone plus vancomycin in patients aged between 2 months and 17 years with complicated CAP. Clinical response rates in the modified intention-to-treat population were 52% (15/29 patients) in the ceftaroline fosamil group and 67% in the comparator group (6/9); clinical stability at Study Day 4 was 21% (6/29) and 22% (2/9), respectively. Ceftaroline fosamil was well tolerated and the clinical response rates were similar to that of ceftriaxone plus vancomycin.