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AstraZeneca reports top-line results from Phase 3 antibiotic trials

  • AstraZeneca (NYSE:AZN) discloses top-line results from two Phase 3 clinical trials evaluating the safety and efficacy of CAZ-AVI (ceftazidime-avibactam) as a treatment for hospitalized patients with complicated intra-abdominal infections. CAZ-AVI was administered as a two-hour IV infusion plus metronidazole compared to meropenem administered as a 30-minute IV infusion.
  • CAZ-AVI demonstrated non-inferiority (no worse than) to meropenum but nothing is disclosed about achieving the primary endpoint of a clinical cure rate 28 to 35 days after randomization. The adverse event rate was similar to meropenem.
  • CAZ-AVI is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections. It consists of ceftazidime, a third-generation antipseudomonal cephalosporin and avibactam, a next-generation non-beta lactam beta-lactamase inhibitor. The additional of avibactam prevents ceftazidime from being broken down by serine-beta-lactamases which are produced by certain bacteria.
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