- Merck's combo antibiotic Zerbaxa (ceftolozane/tazobactam) is intended for use in treating complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
- Zerbaxa was studied in clinical trials focusing on cUTI and also cIAI.
- Zerbaxa, which was approved by the FDA in December 2014 and acquired by Merck the same month, was developed by Cubist Pharmaceuticals.
Merck's cUTI study included 1,083 subjects, who received either IV Zerbaxa of IV levofloxacin (current standard of care) for seven days. With respect to cIAI, patients received either IV Zerbaxa plus metronidazole or IV meropenem for seven days.
Although the primary endpoint of non-inferiority was achieved for cUTI, in the cIAI study, it was not clear whether the trial actually met its primary endpoint of statistical noninferiority as measured by the clinical cure rate 24 to 32 days after initiation of therapy.
Nonetheless, given the rapid rise of multi-drug resistant infections, development of alternative antibiotics is critical.