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Safety Profile Summary
Prescribing Information
Proven clinical efficacy across four Phase III, international, randomised, non-inferiority trials in 1423 adult patients with cUTI, cIAI* or HAP/VAP1–4
REPRISE
cIAI/cUTI, including pyelonephritis2
REPROVE
HAP/VAP3
RECAPTURE
cUTI, including pyelonephritis4
RECLAIM
cIAI1
The efficacy of ZAVICEFTA (ceftazidime–avibactam) for the treatment of adult patients with bacteraemia in association with HAP/VAP, cIAI or cUTI is supported by data from a subset of 101 adult patients across the Phase III clinical trial programme5†
Data support the use of ZAVICEFTA in adult patients with limited treatment options due to KPC and OXA-48 resistance mechanisms, and MDR Pseudomonas including in:6–20
- Primary bacteraemia
- cSSTI
- BJI
- Meningitis
- Febrile neutropenia
- Cystic fibrosis
- Post-transplant patients
* ZAVICEFTA is as effective as a carbapenem when combined with metronidazole in hospitalised patients with Gram-negative cIAIs.1
† Five Phase III, international, randomised, non-inferiority trials in patients with HAP/VAP, cIAI or cUTI.5,21
ZAVICEFTA (ceftazidime–avibactam) 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 and avibactam examining its efficacy against ceftazidime-resistant Gram-negative pathogens.
Baseline pathogens
Ceftazidime-resistant Enterobacterales (most commonly E. coli or K. pneumoniae) and P. aeruginosa
* Formal statistical comparison not performed; corresponding CIs for the efficacy of best-available therapy were used to provide context for descriptive estimates of ceftazidime and 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.
ZAVICEFTA (ceftazidime–avibactam) is as effective as a carbapenem in patients with HAP/VAP caused by Gram-negative pathogens3
REPROVE Phase III trial:
- 879 hospitalised adults with HAP/VAP
- The first randomised controlled trial to show non-inferiority, compared with a carbapenem, of a new antimicrobial therapy targeting Gram-negative pathogens in HAP/VAP.
Baseline pathogens
Predominantly K. pneumoniae and P. aeruginosa including some ceftazidime-resistant strains
100 patients (28%) had ≥1 ceftazidime-resistant isolate
* Non-inferiority was concluded if the lower limit of the 95% CI was greater than -12.5%.
† cMITT population comprised patients with minimum disease criteria but excluded patients with only non-target pathogens. cMITT population comprised patients with minimum disease criteria but excluded patients with only non-target pathogens.
‡ The CE population comprised patients in the cMITT population who received an adequate course of treatment and had an assessable clinical outcome within the assessment window, no protocol deviations that could affect the assessment of efficacy, and no unacceptable previous or concomitant antibiotics
ZAVICEFTA (ceftazidime–avibactam) is as effective as a carbapenem in patients with cUTI caused by Gram-negative pathogens4
RECAPTURE Phase III trial:
- 1033 hospitalised adults with cUTI
Baseline pathogens
Predominantly E. coli and K. pneumoniae including some ceftazidime-resistant strains
* Non-inferiority was concluded if the lower limit of the 95% CI was greater than -12.5%.
† The mMITT population comprised all randomised patients with minimum disease criteria and eligible baseline pathogen(s).
ZAVICEFTA (ceftazidime–avibactam) is as effective as a carbapenem when combined with metronidazole in patients with cIAI caused by Gram-negative pathogens1
RECLAIM Phase III trial:
- 1066 hospitalised adults with cIAI
Baseline pathogens
E. coli, K. pneumoniae and P. aeruginosa including some ceftazidime-resistant strains
417 patients (40%) had polymicrobial infection at baseline
* Non-inferiority was considered met if the lower limit of the 95% CI for between-group difference was greater than the prespecified non-inferiority margin of -12.5%.
† Patients in the MITT population are defined as patients who received study drug and met the clinical disease criteria.
The efficacy of ZAVICEFTA (ceftazidime–avibactam) for the treatment of bacteraemia in adult patients is supported by data from a subset of 101 patients across the Phase III programme5,21,22*
In this post-hoc analysis†, ZAVICEFTA showed favourable clinical and microbiological response rates in adult patients with bacteraemia‡
associated with HAP/VAP, cIAI or cUTI.5,21
Baseline pathogens5
E. coli (69%); K. pneumoniae (21%); P. aeruginosa (17%).
Primary Diagnosis5
Acute pyelonephritis (47%); VAP (15%).
In this post-hoc analysis†, the safety of ZAVICEFTA in patients with bacteraemia was consistent with the known profile in HAP/VAP,cIAI and cUTI, and is consistent with both cephalosporins and carbapenems.1-4
* Five Phase III international, randomised, non-inferiority trials in patients with HAP/VAP, cIAI or cUTI.21,22
† Exploratory analysis of adult patients with Gram-negative bacteraemia.5
‡ Defined as any patient with ≥1 bacteria identified from a blood culture at baseline for all studies, except for RECAPTURE, which also required the same pathogen to be identified in a urine sample at >105 CFUs/mL.21
§ Meropenem in HAP/VAP and cIAI; doripenem in cUTI.21
|| ZAVICEFTA plus metronidazole for cIAI.21
Prescribing information
solution for infusion)
Shields RK, et al. Antimicrob Agents Chemother 2017;61:e00883-17
Atkin SD, et al. Infect Drug Resist 2018;11:1499–510
ZAVICEFTA. Summary of Product Characteristics.
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