Information on how to access prescribing information and adverse event reporting can be found at the bottom of the page.
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) |
||
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 |
||
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) |
||
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) |
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
**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
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
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.
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-PFE-GBR-3863. November 2021
No
OK, We will need you to sign in before we can determine if you are aligned with a Pfizer promotional colleague.This is an interstitial message to prompt a HCP before they login.
If you have already registered with pfizerpro.co.uk and select ‘yes’, you will be directed to the sign-in page where you will be required to enter your username and password.
Would you like to register or sign in now?