Zinforo Efficacy

Prescribing information is available at the bottom of this page.

Zinforo® High clinical cure rate and evidence of rapid response in CAP

In Phase III trials, overall clinical cure rates were similar between Zinforo® and ceftriaxone:2
  • 84.3% vs 77.7% (CE population)
  • 82.6% vs 76.6% (MITTE population)
70% of Zinforo® treated patients achieved clinical stability and improvement of symptoms by Day 4*†3
 
FOCUS 1 and 2: Clinical response rates at Day 4*†3

 

Consistently high early clinical response rates at Day 4, including for Streptococcus pneumoniae infections3

 

Zinforo® delivers high cure rates in patients with severe disease, risk factors for difficult-to-treat infections and comorbidities2

 

Zinforo® efficacy confirmed in CAP patients in a real-world setting

Clinical success in selected subgroups of the CAPTURE study ||⁴,⁵

 

 

 

High rates of overall clinical success observed across various real-world patient subgroups ||⁴,⁵

Footnotes: 

*Zinforo® may be associated with early clinical response, based on clinical stability and symptom improvement criteria. Early clinical response does not predict final clinical outcome for Zinforo®.3

Shown not to be statistically significant.3

CrCI 31–50 mL/min.2

§ Bacteraemia was present in 4% of patients when baseline medical characteristics were assessed.2

|| CAPTURE was a retrospective cohort study relating to current treatment practice in the US. In CAPTURE, 'clinical success' was defined as clinical cure with no further need for antibiotic therapy or clinical improvement with switch to oral agents at end of Zinforo® treatment. As CAPTURE is a retrospective chart review study, it has the limitations inherent to this study design.3,4

Abbreviations: CAP, community-acquired pneumonia; CAPTURE, Clinical Assessment Program and TEFLARO Utilization Registry; CE, clinically evaluable; CrCl, creatinine clearance; FOCUS, CeFtarOline Community-acquired pneumonia trial vs ceftriaxone in hospitalised patients; MITTE, modified intent-to-treat efficacy; PORT, Pneumonia Patient Outcomes Research Team.
References: 1. Zinforo®. Summary of Product Characteristics; 2. File TM, et al. Clin Infect Dis 2010;51:1395–405; 3. Eckburg P, et al. Infect Dis Clin Pract 2012;20:254–60; 4. Udeani G, et al. Hosp Prac 2014;42:109–15; 5. Maggiore C, et al. Expert Rev Clin Pharmacol 2015;8:141–53.

 

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-0109. March 2020

Zinforo® High clinical cure rate and evidence of rapid response  with cSSTI

In Phase III trials, overall clinical cure rates were similar between Zinforo® and vancomycin + aztreonam:*2

  • 91.6% vs 92.7% (CE population)

  • 85.9% vs 85.5% (MITT population)

74% of Zinforo® treated patients achieved clinical stability and improvement of symptoms by Day 3†3

 

 

Zinforo® was associated with a trend towards early clinical response when compared to vancomycin + aztreonam at Day 33

Be confident with Zinforo® in challenging clinical scenarios with cSSTI

Zinforo® delivers high cure rates in patients with severe disease and comorbidities*2

Clinical response rates at TOC by subgroup (CANVAS 1 & 2)

 

 

Zinforo® efficacy confirmed in cSSTI patients in a real-world setting

Clinical success in selected subgroups of the CAPTURE study§4–6

 

Clinical success rate of 85% with Zinforo® in cSSTI in real-world patients5 

 

Footnotes: 

*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.1
Zinforo® was associated with a non-statistical significant early clinical response defined by cessation of lesion spread and absence of fever.3
Bacteraemia was present in 4% of patients when baseline medical characteristics were assessed.2
§
CAPTURE was a retrospective cohort study relating to current treatment practice in the US. In CAPTURE, 'clinical success' was defined as clinical cure with no further need for antibiotic therapy or clinical improvement with switch to oral agents at end of Zinforo® treatment. As CAPTURE is a retrospective chart review study, it has the limitations inherent to this study design.4–6
||
Zinforo® is suitable for patients with a range of BMIs, and doesn't need to be dosed on a weight basis.6
Normal/mild renal insufficiency, or moderate or severe renal insufficiency. Overall clinical success rates were 88–91%.3

Abbreviations: BMI, body mass index; CANVAS, CeftAroliNe fosamil vs Vancomycin in Skin and skin structure infection; CAPTURE, Clinical Assessment Program and TEFLARO Utilization Registry; CE, clinically evaluable; cSSTI, complicated skin and soft tissue infections; MITT, modified intent-to-treat; MRSA, methicillin-resistant Staphylococcus aureus; TOC, test-of-cure.
References: 1. Zinforo®. Summary of Product Characteristics; 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. Maggiore C, et al. Expert Rev Clin Pharmacol 2015;8:141–53; 5. Santos PD, et al. J Chemother 2013;25:341–6; 6. Evans JD, et al. Postgrad Med 2014;126:128–34.

 

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-0109. March 2020

Zinforo® Early clinical response in paediatric patients with cSSTI and CAP

In the paediatric cSSTI trial, overall clinical cure rates were similar between ZINFORO® and comparator therapy:*†1

  • 94% vs 87% (MITT population)

80% of Zinforo® treated patients achieved clinical response by Day 32

 

Clinical response rates at Day 3 (MITT population)2

 

In the paediatric CAP trial, overall clinical cure rates were similar between Zinforo® and ceftriaxone:3

  • 88% vs 89% (MITT population)

69% of Zinforo® treated patients achieved clinical response by Day 43

 

Clinical response rates at Day 4 (MITT population)4

 

Footnotes: The studies were not powered for comparative inferential efficacy analysis, and no efficacy endpoint was identified as primary.2,3
*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.1
Evaluated 8–15 days after the last dose of any antibiotic (IV or oral).
Cessation of spread measured by total length and width separately, and temperature ≤37.6°C.

Abbreviations: CAP, community-acquired pneumonia; cSSTI, complicated skin and soft-tissue infection; IV, intravenous; MITT, modified intention-to-treat.
References: 1. Zinforo® Summary of Product Characteristics; 2. Korczowski B, et al. Pediatr Infect Dis J 2016;35:e239–47; 3. 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-0109. March 2020