About Zinforo

Prescribing information is available at the bottom of this page.

About Zinforo®: An extended-spectrum treatment for patients with CAP or cSSTI

Zinforo® is a fifth-generation cephalosporin with an extended spectrum of activity* relative to third-generation compounds2

About Zinforo

Footnotes: *Efficacy has been demonstrated in CAP clinical studies against the following pathogens that were susceptible to ceftaroline in vitro: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible strains only), Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, and Klebsiella pneumoniae.1 Efficacy has been demonstrated in cSSTI clinical studies against the following pathogens that were susceptible to Zinforo®in vitro: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group, Streptococcus dysgalactiae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca and Morganella morganii.1
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 

Abbreviations: CAP, community-acquired pneumonia; cSSTI, complicated skin and soft tissue infections; ELF, epithelial lining fluid; ESBL, extended spectrum β-lactamases; PBP, penicillin binding protein.
References: 1. Zinforo®. Summary of Product Characteristics; 2. Laudano JB. J Antimicrob Chemother 2011;66(Suppl. 3):iii11–iii18; 3. Garrison MW, Kawamura NM, Wen MM. Expert Rev Anti Infect Ther 2012;10:1087–103; 4. Drusano,
 GL. J Antimicrob Chemother 2011;66(Suppl3):iii61–7; 5. Riccobene TA, et at. Antimicrob Agents Chemother 2016;60:5849–57.

 

Prescribing Information

Zinforo® 600 mg powder for concentrate for solution for infusion: SPC
Legal category: POM
Basic NHS cost: 10 vial pack £375.00

PP-ZFO-GBR-0072. March 2020

Zinforo® MoA Video

Click on the video below to explore Zinforo's® mode of action 


Abbreviations: CAP, community-acquired pneumonia; cSSTI, complicated skin and soft tissue infections; MoA, mechanism of action.
References: 1. Zinforo®. Summary of Product Characteristics.

 

Prescribing Information

Zinforo® 600 mg powder for concentrate for solution for infusion: SPC
Legal category: POM
Basic NHS cost: 10 vial pack £375.00

PP-ZFO-GBR-0072. March 2020

Pivotal Phase III Zinforo® CAP studies

The efficacy and tolerability of Zinforo® monotherapy has been consistently demonstrated in six large, double-blind, Phase III , randomised, controlled clinical trials - three involving adult patients with cSSTI  and three in patients with CAP.2–5
Zinforo® safety and efficacy has also been examined in two clinical studies involving paediatric patients with cSSTI and CAP.6,7

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Primary endpoint outcomes2

Clinical cure rates: FOCUS 1 and 2 

  • Zinforo® 600 mg every 12 hours demonstrated comparable efficacy vs ceftriaxone 1 g every 24 hours in terms of clinical cure rates
The lower limit of the 95% CI was above –10%, which met the predefined criteria for non-inferiority.6
Zinforo® was well tolerated with a safety profile similar to that of ceftriaxone.6

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Primary endpoint outcomes3

Clinical cure rates: Asia CAP

  • Zinforo® 600 mg every 12 hours demonstrated superior efficacy vs ceftriaxone 2 g every 24 hours 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 superiority would be concluded if the lower limit of the 95% CI ≥0%.3
The safety profile of Zinforo® was similar to that observed in the pooled Phase III CAP and cSSTI studies.3

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Primary endpoint outcomes11

  • Zinforo® was well tolerated in paediatric patients hospitalised with CAP
  • Clinical cure rates at TOC in the MITT population were high: 88% Zinforo® and 89% ceftriaxone
  • Adverse events were reported in a similar percentage of patients in the Zinforo® group 45% and ceftriaxone group 46%

 

Footnotes: *This study was not powered for comparative inferential analysis.7
Abbreviations: CAP, community-acquired pneumonia; CE, clinically evaluable; CI, confidence interval;cSSTI, complicated skin and soft tissue infections; EOT, end of treatment; FOCUS, CeFtarOline Community-acquired pneumonia trial vs ceftriaxone in hospitalised patients; ITT, intent-to-treat; IV, intravenous; LFU, late follow-up; ME, microbiologically evaluable; MITT, modified intent-to-treat; MITTE, modified intent-to-treat efficacy; mMITTE, microbiological modified intent-to-treat efficacy; PORT, Pneumonia Patient Outcomes Research Team; TOC, test of cure.
References: 1. Zinforo®. Summary of Product Characteristics; 2. File TM, Low DE, Eckburg PB, et al. Clin Infect Dis 2010;51:1395–405; 3. Zhong N, et al. Lancet Infect Dis 2015;15:161–71; 4. Corey G, et al. Clin Infect Dis 2010;51:641–50; 5. Dryden M, et al. J Antimicrob Chemother 2016;71:3575–84; 6. Korczowski B, et al. Pediatr Infect Dis J 2016;35:e239–47; 7. Cannavino CR, et al. Pediatr Infect Dis J 2016;35:752–9.

 

Prescribing Information

Zinforo® 600 mg powder for concentrate for solution for infusion: SPC
Legal category: POM
Basic NHS cost: 10 vial pack £375.00

PP-ZFO-GBR-0072. March 2020

Pivotal Phase III Zinforo® cSSTI studies

The efficacy and tolerability of Zinforo® monotherapy has been consistently demonstrated in six large, double-blind, Phase III, randomised, controlled clinical trials - three involving adult patients with cSSTI  and three in patients with CAP.2–5
Zinforo® safety and efficacy has also been examined in two clinical studies involving paediatric patients with cSSTI and CAP.6,7

 

Zinforo Canvas
Primary endpoint outcomes4

Clinical cure rates: CANVAS 1 and 2 

  • Zinforo® 600 mg every 12 hours demonstrated comparable efficacy vs vancomycin plus aztreonam1 g every 12 hours in terms of clinical cure rates
The lower limit of the 95% CI was above –10%, which met the predefined criteria for non-inferiority.4
Zinforo® was well tolerated with a safety profile consistent with the cephalosporin class.4

 

Zinforo covers
Primary endpoint outcomes5

Clinical cure rates: COVERS

  • Zinforo® 600 mg every 12 hours demonstrated non-inferiority vs vancomycin plus aztreonamin terms of clinical cure rates
 

Non-inferiority was defined as a lower limit of the 95% Cl ≥–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% Cl ≥0%.5
The safety profile of Zinforo® 600 mg every 8 h was similar to those in previous trials of 600 mg every 12 h, with no new safety signals identified.5
cssti_paediatric_study
Primary and secondary endpoint outcomes6
  • Zinforo® was as well tolerated and effective in paediatric patients with cSSTI as the comparator
  • Clinical cure rates at TOC were high: 94% Zinforo® and 87% comparator
  • Treatment-emergent adverse events were reported in a similar percentage of patients in the Zinforo® group 22% and comparator group 23%

Abbreviations: CAP, community-acquired pneumonia;  CANVAS, CeftAroliNe fosamil vs Vancomycin in Skin and skin structure infection; CE, clinically evaluable; CI, confidence interval; COVERS, CeftarOline versus Vancomycin and aztrEonam tReating cSSTI; cSSTI, complicated skin and soft tissue infections; IV, intravenous; LFU, late follow-up; ME, microbiologically evaluable; MITT, modified intent-to-treat; mMITT, microbiological modified intent-to-treat; PK, pharmacokinetic; TOC, test of cure.
References: 1. Zinforo®. Summary of Product Characteristics; 2. File TM, Low DE, Eckburg PB, et al. Clin Infect Dis 2010;51:1395–405; 3. Zhong N, et al. Lancet Infect Dis 2015;15:161–71; 4. Corey G, et al. Clin Infect Dis 2010;51:641–50; 5. Dryden M, et al. J Antimicrob Chemother 2016;71:3575–84; 6. Korczowski B, et al. Pediatr Infect Dis J 2016;35:e239–47; 7. Cannavino CR, et al. Pediatr Infect Dis J 2016;35:752–9.

 

Prescribing Information

Zinforo® 600 mg powder for concentrate for solution for infusion: SPC
Legal category: POM
Basic NHS cost: 10 vial pack £375.00

PP-ZFO-GBR-0072. March 2020