Results from the Phase 3 TANGO I study, which compared treatment with meropenem/vaborbactam to piperacillin-tazobactam in patients with complicated urinary tract infections (cUTI), have been published in the Journal of the American Medical Association.
Meropenem/vaborbactam is marketed under the brand name Vabomere (Melinta Therapeutics). This combination antibiotic was approved by the Food and Drug Administration (FDA) in August 2017 for the treatment of adults with cUTI, including pyelonephritis, caused by designated susceptible Enterobacteriaceae: Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex.
The Phase 3, multicenter, multinational, randomized trial, Targeting Antibiotic Non-susceptible Gram-negative Organisms (TANGO I) trial (n=550), compared the safety and efficacy of meropenem/vaborbactam to piperacillin/tazobactam in the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis. The primary endpoint was overall success, as defined by clinical cure or improvement plus microbiological eradication at the end of intravenous (IV) treatment in the modified intent-to-treat (ITT) population.
The results showed that meropenem/vaborbactam was non-inferior to piperacillin/tazobactam with an overall success rate of 98.4% vs 94.0% (difference 4.5%, 95% CI: 0.7%, 9.1%; P<0.001). In addition, the rate of adverse events was found to be similar in both the meropenem/vaborbactam and piperacillin/tazobactam groups (39.0% vs 35.5%). Headache, diarrhea, vaginal infection, and infusion site phlebitis were the most common events reported.
“Among patients with complicated UTI, including acute pyelonephritis and growth of a baseline pathogen, meropenem-vaborbactam vs piperacillin-tazobactam resulted in a composite outcome of complete resolution or improvement of symptoms along with microbial eradication that met the noninferiority criterion,” the authors write.
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