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ZAVICEFTA®: Indicated for the treatment of adults with cUTI, cIAI, HAP/VAP and patients with limited treatment options.1*

ZAVICEFTA is as effective as best available therapy in patients with cUTI or cIAI caused by Gram-negative pathogens2

REPRISE Phase III trial: 333 hospitalised adults with a cUTI or cIAI

The REPRISE study is the first pathogen-directed clinical trial for ceftazidime-avibactam examining its efficacy against ceftazidime-resistant Gram-negative pathogens.2

Patients with favourable clinical response at TOC (%)§

Baseline pathogens: Ceftazidime-resistant Enterobacteriaceae (most commonly E. coli or K. pneumoniae) and P. aeruginosa.

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REPROVE Phase III trial:

879 hospitalised adults with HAP and VAP

View trial results

RECAPTURE Phase III trial:

1033 hospitalised adults with cUTI.

View trial results

RECLAIM Phase III trial:

1066 hospitalised adults with cIAI

View trial results


§Formal statistical comparison not performed; corresponding CIs for the efficacy of best available therapy were used to provide context for descriptive estimates of ceftazidime–avibactam efficacy.
Patients in the mMITT population are defined as carrying a pathogen at the start of treatment and who received at least one dose of study drug.
Preferred best available therapy options for cUTI and cIAI were 5–21 days of treatment with meropenem, imipenem, doripenem, colistin and (for cIAI) tigecycline, administered intravenously, but any therapy, including combination treatment, was permitted.
*Consideration should be given to official guidance on the appropriate use of antibacterial agents

Abbreviations:​​​​​​​

AE, adverse event; CE, clinically evaluable; CI, confidence interval; cMITT, clinically modified intention-to-treat; HAP, hospital-acquired pneumonia; K. pneumoniae, Klebsiella pneumoniae; P. aeruginosa, Pseudomonas aeruginosa; TOC, test of cure; VAP, ventilator-associated pneumonia; cIAI, complicated intra-abdominal infection; E.coli, Escherichia coli; MITT, modified intention-to-treat; cUTI, complicated urinary tract infection.

References:
  1. ZAVICEFTA. Summary of Product Characteristics;
  2. Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73
PP-ZVA-GBR-1288. September 2021

Learn more about the tolerability data of ZAVICEFTA from four Phase III clinical trials.

View safety profile

Dr Matthew Dryden, Consultant Microbiologist at Hampshire Hospitals, discusses the REPRISE study.

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PP-PFE-GBR-2688. December 2020

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