How effective is Zerbaxa?
The efficacy and safety of Zerbaxa were determined in the following clinical trials:
In Complicated Intra-abdominal Infections (cIAI)
In a multinational, double-blind, randomized, phase 3 trial, the efficacy of Zerbaxa with metronidazole was compared to meropenem. A total of 979 adults hospitalized with cIAI received Zerbaxa 1.5 g (1 g/0.5 g IV) plus metronidazole (500 mg IV) or meropenem (1 g IV) for 4 to 14 days.
The clinical cure rates at 24 to 32 days after initiation of therapy were 83% in Zerbaxa and metronidazole arm and 87.3% in the meropenem arm. Zerbaxa in combination with metronidazole showed comparable efficacy to meropenem.
In Complicated Urinary Tract Infections( cUTI) including Pyelonephritis
In a multinational, double-blind, randomized study, the efficacy of Zerbaxa was compared with levofloxacin. A total of 1068 adults hospitalized with cUTI including pyelonephritis received Zerbaxa 1.5 g (1 g/0.5 g IV) every 8 hours or levofloxacin (750 mg IV) once daily for 7 days.
The composite microbiological and clinical cure rates after the initiation of therapy were 76.9% in the Zerbaxa group and 68.4% in levofloxacin group. Zerbaxa was more effective than levofloxacin.
Interesting facts about Zerbaxa
Zerbaxa was designated as a Qualified Infectious Disease Product (QIDP) by the FDA.
Zerbaxa may not be as effective in patients with renal impairment.
Ceftolozane is a new type of cephalosporin.
What are the side effects of Zerbaxa?
The most common side effects associated with Zerbaxa during clinical studies include nausea, diarrhea, headache, pyrexia, constipation, vomiting, insomnia, and hypokalemia (low potassium). Serious allergic reactions and clostridium difficile associated diarrhea (CDAD) have also been reported during treatment with Zerbaxa.
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