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AboutUnmet NeedCommunity-acquired PneumoniaComplicated Skin & Soft Tissue InfectionsMode of ActionVideoCommunity-acquired PneumoniaComplicated Skin & Soft Tissue InfectionsPatient ProfilesProfiles of Patients With CAPIdentify ZINFORO® Patient With CAPProfiles of Patients With cSSTIIdentify ZINFORO® Patient With cSSTIDosingRecommended Dosing ScheduleSimple DosingRenal AdjustmentEfficacyCommunity-acquired PneumoniaClinical Efficacy: Proven Clinical EfficacyClinical Efficacy: Evidence of Rapid ResponsePivotal Clinical StudiesMicrobiology: Optimising OutcomesMicrobiology: CoverageMicrobiology: Low MIC ValuesComplicated Skin & Soft Tissue InfectionsClinical Efficacy: Proven Clinical EfficacyClinical Efficacy: Evidence of Rapid ResponsePivotal Clinical StudiesMicrobiology: Optimising OutcomesMicrobiology: CoverageMicrobiology: Low MIC ValuesSafetySafetyKey safety featuresLow Incidence of Discontinuation in CAPLow Incidence of Discontinuation in cSSTIClinical & Scientific Data Clinical & Scientific Data Efficacy in the Treatment of CAPClinical Cure Rates Against Relevant PathogensClinical Cure Rates Across Patient SubgroupsDemonstrated Superiority to CeftriaxoneEarly Clinical ResponseReal-world Efficacy in Elderly PatientsConsistent Clinical Cure Rates in cSSTIClinical Cure Rates in Common Causative PathogensClinical Cure Rates in Patients With ComorbiditiesEarly Clinical EfficacyReal-life Efficacy in Clinical PracticeSupport & ResourcesSupport & ResourcesClinical updatesPrescribing InformationVideosWebinarsExplore Materials

Pivotal Clinical Studies

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
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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
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Primary end point outcomes3
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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.
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References:

File TM Jr, Low DE, Eckburg PB, et al. Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubled-blinded, multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia [published correction appears in Clin Infect Dis. 2011 Apr 1;52(7):967]. Clin Infect Dis. 2010;51(suppl 12):1395-1405.Zhong NS, Sun T, Zhuo C, et al. Ceftaroline fosamil versus ceftriaxone for the treatment of Asian patients with community-acquired pneumonia: a randomised, controlled, double-blind, phase 3, non-inferiority with nested superiority trial. Lancet Infect Dis. 2015;15(suppl 2):161-171.Corey GR, Wilcox M, Talbot GH, et al. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010;51(suppl 6):641-650.Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016;71(suppl 12):3575-3584.Korczowski B, Antadze T, Giorgobiani M, et al. A Multicenter, Randomized, Observer-blinded, Active-controlled Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Comparator in Pediatric Patients With Acute Bacterial Skin and Skin Structure Infection. Pediatr Infect Dis J. 2016;35(suppl 8):e239-e247.Cannavino CR, Nemeth A, Korczowski B, et al. A Randomized, Prospective Study of Pediatric Patients With Community-acquired Pneumonia Treated With Ceftaroline Versus Ceftriaxone. Pediatr Infect Dis J. 2016;35(suppl 7):752-759.


​​​​​Please click the Prescribing Information link to view the safety and adverse events information of ZINFORO®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
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PP-ZFO-IND-0417 June 2022

Complicated Skin & Soft Tissue Infections
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Fifth-generation cephalosporin with broad coverage

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Dosing

Simple dosing with a flexible infusion time

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Safety

Safety profile consistent with other cephalosporins

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Clinical & Scientific Data

​​​​ZINFORO® in the treatment of CAP and cSSTI​​​​​​

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