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Comparison of the in vivo efficacy of the ceftarolinefosamil, vancomycin and daptomycin in a murine model of methicillin-resistant Staphylococcus aureus bacteraemia. The need for alternative drugs to treat methicillin-resistant Staphylococcus aureus (MRSA) bacteraemia has led to some focus being placed on ceftaroline for which clinical data remain scarce. Here we compared the efficacy of ceftarolinefosamil for the treatment of experimental MRSA bacteraemia relative to that of approved therapies. Five MRSA strains were tested in an immunocompetent BALB/c bacteraemia model. Serum pharmacokinetics of ceftarolinefosamil was determined by HPLC/MS Q-TOF. Two hours after infection with the MRSA strains, mice were administered 50 mg/kg of ceftarolinefosamil every 6 hours, for 24 hours
Ceftarolinefosamil (Zinforo) - treatment of complicated skin and soft tissue infections in children from the age of 2 months or community-acquired pneumonia in children from the age of 2 months
Efficacy and Safety of CeftarolineFosamil in Hospitalized Patients with Community-Acquired Pneumonia in China: Subset Analysis of an International Phase 3 Randomized Controlled Trial. Ceftarolinefosamil has demonstrated superior clinical efficacy versus ceftriaxone for hospitalized adults with moderate-to-severe community-acquired pneumonia (CAP) in a Phase 3 trial in Asia and in a meta -analysis of three trials in Asia, North America, and Europe. Efficacy and safety outcomes for the subset of patients in China in the ASIA CAP trial were analyzed to determine if the same conclusions hold in the China subpopulation. Hospitalized adults with Pneumonia Outcomes Research Team risk class III-IV CAP were randomized (1:1) to receive either intravenous ceftarolinefosamil 600 mg every 12 h
Treatment outcomes of secondary bacteraemia in patients treated with ceftarolinefosamil: pooled results from six phase III clinical trials. This exploratory pooled analysis assessed the efficacy and safety of ceftarolinefosamil and comparators across six phase III clinical trials in adults with community-acquired pneumonia (CAP) or complicated skin and soft-tissue infection (cSSTI ) and secondary bacteraemia. In each trial, FOCUS 1 and 2 (CAP), Asia CAP trial, CANVAS 1 and 2 (cSSTI) and COVERS (cSSTI), patients were randomised to ceftarolinefosamil [600 mg q12h by 1-h i.v. infusion, except in COVERS (600 mg q8h by 2-h i.v. infusion), adjusted for renal function] or comparator. Efficacy assessments included clinical and microbiological responses at test-of-cure visit [microbiological
Plasma and Lung Tissue Pharmacokinetics of CeftarolineFosamil in Patients Undergoing Cardiac Surgery with Cardiopulmonary Bypass: an In Vivo Microdialysis Study. Ceftarolinefosamil, a fifth-generation cephalosporin antibiotic with activity against methicillin-resistant Staphylococcus aureus (MRSA), is currently approved for the treatment of pneumonia and complicated skin and soft tissue included in this study and randomly assigned to intermittent or continuous administration. Eighteen hundred milligrams of ceftarolinefosamil was administered intravenously as either 600 mg over 2 h every 8 h (q8h) (intermittent group) or 600 mg over 2 h (loading dose) plus 1,200 mg over 22 h (continuous group). Interstitial lung tissue concentrations were measured by microdialysis. Relevant
Phase 2 Study of the Safety, Pharmacokinetics and Efficacy of CeftarolineFosamil in Neonates and Very Young Infants With Late-onset Sepsis. With increasing antimicrobial resistance, antibiotic treatment options for neonatal late-onset sepsis (LOS) are becoming limited. Primary objective of this study was assessment of the safety of ceftarolinefosamil in LOS. Eligible neonates and very young infants 7 to <60 days of age with LOS were enrolled in this phase 2, open-label, multicenter study (NCT02424734) and received ceftarolinefosamil 4 or 6 mg/kg every 8 hours by 1-hour intravenous infusion plus intravenous ampicillin and optional aminoglycoside for 48 hours-14 days. Safety was assessed through the final study visit (21-35 days after the last study therapy dose). Efficacy, assessed
Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of CeftarolineFosamil Versus Vancomycin Plus Aztreonam. Exploratory analyses evaluated patient characteristics and outcomes among patients with complicated skin and soft tissue infection (cSSTI) in the phase 3 COVERS study who were admitted to an intensive care unit (ICU). Adults with cSSTI (surface area ≥ 75 cm) and evidence of systemic inflammation and/or underlying comorbidities were randomized 2:1 to intravenous ceftarolinefosamil (600 mg every 8 h [q8h]) or vancomycin (15 mg/kg every 12 h) plus aztreonam (1 g q8h) for 5-14 days. Clinical response and ICU length of stay (LOS) within first
Use of CeftarolineFosamil in Osteomyelitis: CAPTURE Study Experience. Osteomyelitis is often challenging to treat. This analysis examined the clinical experience of patients with gram-positive osteomyelitis treated with ceftarolinefosamil in the phase 4 Clinical Assessment Program and Teflaro® Utilization Registry (CAPTURE) study. Data including patient demographics, past illnesses, risk factors, disease characteristics, antibiotic use, pathogens isolated, and clinical outcome were collected between September 2013 and February 2015 by review of randomly ordered patient charts from participating sites in the United States. Clinical success was defined as discontinuation of ceftarolinefosamil following clinical cure with no further need for antibiotics or clinical improvement with switch
Ceftarolinefosamil as a potential treatment option for Staphylococcus aureus community-acquired pneumonia in adults. Staphylococcus aureus (S. aureus), including methicillin-resistant S. aureus (MRSA), is an important aetiological cause of community-acquired pneumonia (CAP) and associated with significant morbidity and mortality. Empiric therapy for CAP frequently consists of β-lactam monotherapy or β-lactam/macrolide combination therapy. However, such agents are often ineffective against S. aureus and do not reflect the emergence and increasing prevalence of MRSA in the community setting. Ceftarolinefosamil is a fifth-generation parenteral cephalosporin with broad-spectrum activity against Gram-positive pathogens - such as S. aureus (including MRSA), Streptococcus pneumoniae
Ceftarolinefosamil therapy in patients with acute bacterial skin and skin-structure infections with systemic inflammatory signs: A retrospective dose comparison across three pivotal trials. This post-hoc analysis compared the pharmacokinetics and clinical outcomes of ceftarolinefosamil 600 mg every 12 (q12h) versus every 8 hours (q8h) in patients with acute bacterial skin and skin-structure infection (ABSSSI) and signs of sepsis. Clinical outcomes at test-of-cure in patients with ABSSSI and systemic inflammatory signs/systemic inflammatory response syndrome (SIRS) as well as ceftaroline minimum inhibitory concentrations (MICs) against baseline pathogens were compared between the COVERS trial (ceftarolinefosamil 600 mg q8h, 2-h infusion) and the CANVAS 1 and 2 trials (ceftarolinefosamil 600
Ceftarolinefosamil for the treatment of Gram-positive endocarditis: CAPTURE study experience. The clinical experience of ceftarolinefosamil (CPT-F) therapy for Gram-positive infective endocarditis is reported from CAPTURE, a retrospective study conducted in the USA. Data, including patient demographics, medical history, risk factors, microbiological aetiology and clinical outcomes, were
Open-Label Randomized Trial of Early Clinical Outcomes of CeftarolineFosamil Versus Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections at Risk of Methicillin-Resistant Staphylococcus aureus. Acute bacterial skin and skin structure infections (ABSSSIs) remain among the most common infectious processes seen in the clinical setting. For patients with complicated
Population Pharmacokinetic Modeling and Probability of Target Attainment Analyses in Asian Patients With Community-Acquired Pneumonia Treated With CeftarolineFosamil. Efficacy of ceftarolinefosamil, the prodrug of the active metabolite ceftaroline, was demonstrated in a phase 3 study of hospitalized Asian patients with Pneumonia Outcomes Research Team (PORT) risk class III-IV community -acquired pneumonia (NCT01371838). The objectives of the current analysis were to expand an existing ceftaroline and ceftarolinefosamil population pharmacokinetic (PK) model with data from this phase 3 study and a phase 1 study (NCT01458743) assessing ceftaroline PK in healthy Chinese volunteers and to evaluate the probability of PK/pharmacodynamic (PK/PD) target attainment (PTA) in Asian patients
Ceftarolinefosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. To describe the pharmacokinetic/pharmacodynamic (PK/PD) modelling and microbiological data that were used to support the recent European approval of ceftarolinefosamil 600 mg q8h by 2 h intravenous (iv) infusion for patients with complicated skin and soft tissue infections (cSSTIs ) caused by Staphylococcus aureus with ceftaroline MICs of 2 or 4 mg/L, and the associated EUCAST MIC breakpoint update for q8h dosing (intermediate = 2 mg/L and resistant >2 mg/L). A population PK model for ceftaroline and ceftarolinefosamil was developed using PK data from 21 clinical studies. The final model was used to simulate PTA in patients with cSSTI receiving ceftarolinefosamil 600 mg q12h
Summary of the safety and tolerability of two treatment regimens of ceftarolinefosamil: 600 mg every 8 h versus 600 mg every 12 h. The recommended adult dose of ceftarolinefosamil is 600 mg q12h by 1 h intravenous (iv) infusion for 5-14 days in complicated skin and soft tissue infection (cSSTI) and 5-7 days in community-acquired pneumonia (CAP). A dosage of 600 mg q8h by 2 h iv infusion is approved in some regions for cSSTI patients with Staphylococcus aureus infection where the ceftaroline MIC is 2 or 4 mg/L. This analysis compares the safety profiles of the q8h and q12h regimens. Safety data from six Phase III, randomized, double-blind clinical trials were collated into the q8h cSSTI pool (ceftarolinefosamil n = 506; NCT01499277) and the q12h pool {ceftarolinefosamil n = 1686
Early use of ceftarolinefosamil in the United States Veterans Health Care System Ceftarolinefosamil is US Food and Drug Administration-approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, but it is not known how ceftaroline is being used in real-world settings or how adverse effects (AEs) and mortality compare to clinical trials