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news.AstraZeneca has unveiled positive results from a phase III trial of its Zavicefta antibiotic, a fixed dose combination of two active substances, ceftazidime and avibactam.
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The Reprove trial evaluated the efficacy of Zavicefta compared to meropenem in the treatment of adult patients with hospital-acquired pneumonia, including ventilator-associated pneumonia.
The antibiotic met the primary goal of statistical non-inferiority compared to meropenem at the test of cure visit, day 21 from randomization.
AstraZeneca said all-cause mortality rate at day 28 from randomization was also same in both the groups.
The company expects to present the full results from the trial at future scientific meetings.
AstraZeneca antibiotics business unit managing director Hans Sijbesma said: “The positive results from this important Phase III trial validate our science-led approach and confirm the effectiveness of Zavicefta in treating hospital-acquired pneumonia, providing patients and physicians with a much-needed new treatment option in the fight against antibiotic-resistant pathogens.”
Zavicefta is intended to treat a range of serious Gram-negative bacterial infections in hospitalized patients.
The antibiotic had earlier showed non-inferiority to comparators in phase III trials in hospitalised adult patients with cIAI and cUTI.
In addition, Zavicefta demonstrated statistically significant superior efficacy compared to doripenem for the European Medicines Agency-specified primary endpoint in the Recapture trials.
The Reprise trial assessed the efficacy and safety of Zavicefta in patients with cIAI or cUTI infections caused by ceftazidime-resistant Gram-negative pathogens. Efficacy was similar to best available treatment.
Substantially higher microbiological cure rates were also observed in cUTI patients treated with Zavicefta.
Image: The Reprove trial evaluated the efficacy of Zavicefta compared to meropenem in the treatment of adult patients with hospital-acquired pneumonia, including ventilator-associated pneumonia. Photo: courtesy of AstraZeneca.