Date: 2015-04-27
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
Company: AstraZeneca (UK)
Product: Zinforo® (ceftaroline fosamil)
Action
mechanism: antibiotic/cephalosporin. Ceftaroline fosamil is an oxyimino cephalosporin medicinal product. As a cephalosporin, it acts as all beta-lactam agents via inhibition of the peptidoglycan synthesis. With regard to benefits, in humans ceftaroline was shown to be non-inferior to the selected comparative regimens in four phase 3 studies – two studies in each of the approved indications (cSSTI and CAP). In addition, Zinforo® has the ability to bind altered penicillin-binding-proteins of some resistant microorganisms such as methicillin-resistant S.aureus (MRSA) and penicillin-nonsusceptible S.pneumoniae (PNSP). Ceftaroline fosamil is marketed as Teflaro™ in the U.S.
Disease: complicated skin and soft tissue infections (cSSTI)
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On April 27, 2015, AstraZeneca presented new phase III data was also presented for Zinforo® (ceftaroline fosamil), an antibiotic approved for the treatment of adult patients with complicated skin and soft tissue infections (cSSTI) or community-acquired pneumonia (CAP) at 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). The Phase III COVERS trial evaluated the safety and efficacy of ceftaroline fosamil for cSSTI patients with evidence of systemic inflammatory response or underlying comorbidities, administered via a 600 mg IV infusion over 120 minutes every eight hours, rather than the currently approved 600 mg every 12 hours dosing regimen. The study included patients from Asia, Europe, North and South America who were randomised 2:1 to receive ceftaroline fosamil 600 mg every eight hours, or to vancomycin 15 mg/kg every 12 hours plus aztreonam 1 g every eight hours for five to 14 days. Results demonstrated that ceftaroline fosamil was effective and well-tolerated for these patients at the adjusted dose, demonstrating non-inferiority versus vancomycin plus aztreonam. Ceftaroline fosamil was well tolerated with 45.6% and 45.5% patients treated with ceftaroline fosamil and vancomycin plus aztreonam respectively, experiencing ≥1 adverse event. The qualitative safety profile of ceftaroline fosamil 600 mg every eight hours was similar to previous trials with the 12 hour dosing, with no new safety signals identified.
