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Zinforo®: High clinical cure rate and evidence of rapid response in CAP
Clinical cure rates: ASIA CAP2
Study design |
A Phase III, prospective, multicentre (China, Taiwan, Korea, Vietnam and India), randomised, double-blind, non-inferiority with nested superiority trial comparing Zinforo (600 mg IV every 12 hours) vs ceftriaxone (2 g IV every 24 hours) |
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Patient population |
Adult Asian patients ≥18 years of age with PORT risk class III-IV CAP. 763 patients were treated for 5-7 days and evaluated in the MITT population |
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Study objective |
To determine non-inferiority (with nested superiority) in the clinical cure rate of Zinforo compared with ceftriaxone (2 g) in the CE population at TOC (8-15 days after end of treatment) |
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Secondary objectives |
Clinical response at the TOC in the MITT, mMITT, and ME populations; clinical response at EOT; clinical relapse at the LFU visit in patients who were clinically cured at TOC; microbiological response at the TOC; clinical and microbiological response by pathogen at the TOC; and safety (as assessed by adverse events in the safety population) |
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Zinforo 600 mg every 12 hours demonstrated superior efficacy vs ceftriaxone 2 g every 24 hours in terms of clinical cure rates2
Non-inferiority was defined as a lower limit of the 95% CI ≥–10% for the between group difference. If this was achieved the protocol stated superiority would be concluded if the lower limit of the 95% CI ≥0%.2
The safety profile of Zinforo was similar to that observed in the pooled Phase III CAP and cSSTI studies.2-4
Explore More
Read several CAP patient profiles describing potential scenarios where Zinforo could be a treatment of choice.
To learn more about the efficacy of Zinforo in a real-world setting, explore the CAPTURE study.
**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; CI, confidence interval; MITT, modified intent-to-treat; PORT, Pneumonia Patient Outcomes Research Team; MRSA, Methicillin-resistant Staphylococcus aureus.
Prescribing Information
Zinforo® (ceftaroline fosamil)
Great Britain
Zinforo 600 mg powder for concentrate for solution for infusion
Northern Ireland
Zinforo 600 mg powder for concentrate for solution for infusion
- ZINFORO. Summary of Product Characteristics
- Zhong N, et al. Lancet Infect Dis 2015;15:161-71
- File TM, et al. Clin Infect Dis 2010;51:1395–405
- Corey G, et al. Clin Infect Dis 2010;51:641-50
- Laudano JB. J Antimicrob Chemother 2011;66(Suppl.3):iii11-iii18
- Garrison MW, et al. Expert Rev Anti Infect Ther 2012;10:1087-103
- Drusano, GL. J Antimicrob Chemother 2011;66(Suppl3):iii61–7
Explore the outcomes of the other Zinforo Phase III clinical trials in patients with CAP and cSSTI
Tolerability profile of Zinforo
Access data on the tolerability profile of Zinforo as established in key Phase III clinical trials.
** This is an optional area where footnotes can live.
Zinforo has an extended in vitro
spectrum of coverage, including key pathogens in CAP and cSSTI**1,5-7
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