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About ZAVICEFTAClinical EfficacySafety and tolerabilityThe ZAVICEFTA patientFull prescribing informationVideo Resources
Clinical Efficacy
Prescribing information available at the bottom of the page

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ZAVICEFTA® has proven clinical efficacy across four international, randomised, Phase III non-inferiority trials in 1423 adult patients with HABP/VABP, cIAI* or cUTI, including pyelonephritis 1-4 FootnoteZAVICEFTA® is as effective as a carbapenem when combined with metronidazole in hospitalised patients with Gram-negative cIAls.Formal statistical comparison not performed; corresponding Cls 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 1423 adult patients with HABP/VABP, cIAI* or cUTI, including pyelonephritis 1-4 FootnoteZAVICEFTA® is as effective as a carbapenem when combined with metronidazole in hospitalised patients with Gram-negative cIAls.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 on 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 1423 adult patients with HABP/VABP, cIAI* or cUTI, including pyelonephritis 1-4 FootnoteZAVICEFTA® is as effective as a carbapenem when combined with metronidazole in hospitalised patients with Gram-negative cIAls.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.
ZAVICEFTA® has proven clinical efficacy across four international, randomised, Phase III non-inferiority trials in 1423 adult patients with HABP/VABP, cIAI* or cUTI, including pyelonephritis 1-4 FootnoteZAVICEFTA® is as effective as a carbapenem when combined with metronidazole in hospitalised patients with Gram-negative cIAls.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.
AbbreviationsCE - clinically evaluable; CI - confidence interval; cIAI - complicated intra-abdominal infection; cMITT - clinically modified intention-to-treat; cUTI - complicated urinary tract infection; HABP - hospital-acquired bacterial pneumonia; mMITT - microbiologically modified intention-to-treat; MITT - modified intention-to-treat; VABP - ventilator-associated bacterial pneumonia.
ReferencesCarmeli Yet al. Lancet Infect Dis 2016;16:661-73;Torres A, et al. Lancet Infect Dis 2018;18:285-95;Wagenlehner FMet al. Lancet Infect Dis 2016;63:754-62;Mazuski JEet al. Lancet Infect Dis 2016;62:1380-9;Zavicefta® South African Approved Professional Information date of publication (21 September 2021)
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*ZAVICEFTA® South African Approved Professional Information date of publication (21 September 2021).PP-ZVA-ZAF-0029
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