Pivotal Phase III ZINFORO® (ceftaroline fosamil) cSSTI studies
The efficacy and tolerability of ZINFORO® (ceftaroline fosamil) monotherapy have been consistently demonstrated in 6 large, double-blind, Phase III, randomised controlled clinical trials – 3 involving adult patients with cSSTI and 3 in patients with CAP.1-4
The safety and efficacy of ZINFORO® (ceftaroline fosamil) has also been examined in 2 clinical studies involving paediatric patients with CAP and cSSTI.5,6
Header | ||
---|---|---|
Header | Header | Header |
Content | Content | Content |
Content | Content | Content |
Content | Content | Content |
Content | Content | Content |
Content | Content | Content |
Content | Content | Content |
Content | Content | Content |
Content | Content | Content |
Primary end point outcomes3
Clinical cure rates: CANVAS 1 and CANVAS 2
Ceftaroline fosamil ( ZINFORO® ) 600 mg q12h demonstrated comparable efficacy versus vancomycin plus aztreonam 1 g q12h in terms of clinical cure rates.
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 that superiority would be concluded if the lower limit of the 95% CI ≥0.5%. The safety profile of ZINFORO® (ceftaroline fosamil) 600 mg q8h was similar to those in the previous trials of 600 mg q12h, with no new safety signals identified.4
CAP, community-acquired pneumonia; CANVAS, CeftAroliNe fosamil vs Vancomycin in Skin and skin structure infection; CE, clinically evaluable; cSSTI; cSSTI, complicated skin and soft tissue infection; EOT, end of treatment; IV, intravenous; LFU, late follow-up; MITT, modified intent-to-treat; q8h, every 8 hours; q12h, every 12 hours; TOC, test-of-cure.
References:
Fifth-generation cephalosporin with broad coverage
Simple dosing with a flexible infusion time
Safety profile consistent with other cephalosporins
ZINFORO® in the treatment of CAP and cSSTI
These pages are not intended for patients or for members of the general public. The web pages contain promotional content.
If you select 'No', you will be redirected to Pfizer.co.in
For more details on, Who is a Registered Medical Practitioner*, please visit
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf , Page No. 39, Rule 2 part (ee), last accessed on 13th September 2019.
Address: The Capital, A Wing, 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra East, Mumbai - 400051.