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FOCUS 1 and 2 trials: Two Phase III, randomised, double-blind, multinational, multicentre, non-inferiority trials comparing Zinforo (600 mg IV every 12 hours, adjusted for moderate renal impairment) vs ceftriaxone (1 g IV every 24 hours)2
Clinical cure rates: FOCUS 1 and 2||
||The lower limit of the 95% CI was above –10%, which met the predefined criteria for non-inferiority.7 Zinforo was well tolerated with a safety profile similar to that of ceftriaxone.7
‡Zinforo may be associated with early clinical response, based on clinical stability and symptom improvement criteria. Early clinical response does not predict final clinical outcome for Zinforo.
*CrCL 31–50 mL/min.2
† Shown not to be statistically significant.3
§ Bacteraemia was present in 4% of patients when baseline medical characteristics were assessed.2
**Zinforo is not active against Pseudomonas aeruginosa. Like other cephalosporins, Zinforo is not active against ESBL-producing strains. In vitro activity does not always correlate with clinical efficacy.1
CAP, community-acquired pneumonia; cSSTI, complicated skin and soft tissue infections; CE, clinically evaluable; FOCUS, CeFtarOline Community-acquired pneUmonia trial vS ceftriaxone in hospitalised patients; MITTE, modified intent-to-treat efficacy; PORT, Pneumonia Patient Outcomes Research Team. NS, non significant
Zinforo® (ceftaroline fosamil)
Access data on the tolerability profile of Zinforo as established in key Phase III clinical trials
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PP-PFE-GBR-3863. November 2021