Clinical Efficacy

ZINFORO® has proven clinical efficacy across six Phase III, randomised, controlled, double-blind trials in adult patients with cSSTI and CAP1–6

In the CANVAS 1 and CANVAS 2 studies, ZINFORO® was as effective as vancomycin plus aztreonam in adult patients with cSSTI* 1:

The lower limit of the 95% CI for the treatment difference was above –10%, which met the predefined criteria for non-inferiority.1

*There is no experience with ZINFORO® in the treatment of cSSTI in the following patient groups: the immunocompromised, patients with severe sepsis/septic shock, necrotising fasciitis, perirectal abscess and patients with third-degree and extensive burns. There is limited experience in treating patients with diabetic foot infections. Caution is advised when treating such patients.7

There was a trend towards early clinical response at Day 3*2:

*ZINFORO® was associated with a non-statistically significant early clinical response defined by the cessation of spread and absence of fever.2

CAP: community-acquired pneumonia; CE: clinically evaluable; CI: confidence interval; cSSTI: complicated skin and soft-tissue infection; MITT: modified intention-to-treat; MITTE: modified intention-to-treat-efficacy; MRSA: methicillin-resistant Staphylococcus aureus; TOC: test of cure.

References:
1. Corey G, et al. Clin Infect Dis 2010;51:641–50;
2. Friedland HD, et al. Antimicrob Agents Chemother 2012;56:2231–6;
3. Dryden M, et al. J Antimicrob Chemother 2016;71:3575–84;
4. File TM, et al. Clin Infect Dis 2010;51:1395–405;
5. Eckburg P, et al. Infect Dis Clin Pract 2012;20:254–60;
6. Zhong NS, et al. Lancet Infect Dis 2015;15:161–71;
7. ZINFORO® (ceftaroline fosamil). Local Product Document of Ceftaroline; LPDZIN072021.

Ceftaroline fosamil (Zinforo®) high clinical cure rate and evidence of rapid response with cSSTI

74% of ceftaroline fosamil (Zinforo®)-treated patients achieved clinical stability and improvement of symptoms by Day 3.†3

Ceftaroline fosamil (Zinforo™) was associated with a trend towards early clinical response when compared with vancomycin + aztreonam at Day 33

Footnotes:
*There is no experience with Ceftaroline fosamil (Zinforo™) in the treatment of cSSTI in the following patient groups: The immunocompromised; patients with severe sepsis/septic shock; necrotising fasciitis; perirectal abscess; and patients with third-degree and extensive burns. There is limited experience in treating patients with diabetic foot infections. Caution is advised when treating such patients.4
Ceftaroline fosamil (Zinforo™) was associated with a non-statistical significant early clinical response defined by the cessation of lesion spread and absence of fever.3

CE: clinically evaluable; cSSTI: complicated skin and soft tissue infections; MITT: modified intent-to-treat; MRSA: methicillin-resistant Staphylococcus aureus.

References:
1. Ceftaroline fosamil (Zinforo™) LPD, Revision No. 1. Revision Date: 03 August 2017. Ref: CDS Reference Date: August 2016;
2. Corey G, et al. Clin Infect Dis 2010;51:641–50;
3. Friedland D, et al. Antimicrob Agents Chemother 2012;56;2231–6.
4. ZINFORO® (ceftaroline fosamil). Local Product Document of Ceftaroline; LPDZIN072021.

PP-ZFO-IND-0279.  09 December 2021
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