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Clinical efficacy

ZAVICEFTA® has proven clinical efficacy across four international, randomised, Phase III non-inferiority trials in 1,423 patients with HAP/VAP, cIAI* or cUTI3-6

 

In the REPRISE Phase III trial, ZAVICEFTA® was as effective as best available therapy in hospitalised adult patients with cUTI or cIAI caused by Gram-negative pathogens3

*ZAVICEFTA® is as effective as a carbapenem when combined with metronidazole in hospitalised patients with Gram-negative cIAIs.
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 were 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® has proven clinical efficacy across four international, randomised, Phase III non-inferiority trials in 1,423 patients with HAP/VAP, cIAI* or cUTI3-6

 

In the REPROVE Phase III trial, ZAVICEFTA® was as effective as a carbapenem in hospitalised adult patients with HAP/VAP caused by Gram-negative pathogens4

*ZAVICEFTA® is as effective as a carbapenem when combined with metronidazole in hospitalised patients with Gram-negative cIAIs.
Non-inferiority was concluded if the lower limit of the 95% CI was greater than –12.5%.
The 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® has proven clinical efficacy across four international, randomised, Phase III non-inferiority trials in 1,423 patients with HAP/VAP, cIAI* or cUTI3-6

 

In the RECAPTURE Phase III trial, ZAVICEFTA® was as effective as a carbapenem in hospitalised adult patients with cUTI caused by Gram-negative pathogens5

*ZAVICEFTA® is as effective as a carbapenem when combined with metronidazole in hospitalised patients with Gram-negative cIAIs.
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 pathogens.

ZAVICEFTA® has proven clinical efficacy across four international, randomised, Phase III non-inferiority trials in 1,423 patients with HAP/VAP, cIAI* or cUTI3-6

 

In the RECLAIM Phase III trial, ZAVICEFTA® was as effective as a carbapenem when combined with metronidazole in hospitalised adult patients with cIAI caused by Gram-negative pathogens6

*ZAVICEFTA® is as effective as a carbapenem when combined with metronidazole in hospitalised patients with Gram-negative cIAIs.
Non-inferiority was concluded if the lower limit of the 95% CI was greater than –12.5%.
The MITT population comprised patients who received study drug and met the clinical disease criteria.