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Adverse event reporting can be found at the bottom of the page
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Information on how to access prescribing information and adverse event reporting can be found towards the bottom of the page.
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.
879 hospitalised adults with HAP and VAP
1033 hospitalised adults with cUTI.
1066 hospitalised adults with cIAI
§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.
Prescribing information
Click here for ZAVICEFTA® (ceftazidime avibactam) prescribing information
Click here for MERONEM® (meropenem trihydrate) prescribing information
Click here for TYGACIL® (tigecycline) prescribing information in Great Britain
Click here for TYGACIL® (tigecycline) prescribing information in Northern Ireland
References
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
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PP-PFE-GBR-3863. November 2021