TUESDAY, Nov. 1, 2016 (HealthDay News) — For the treatment of adults with complicated urinary tract infections (cUTIs), a combination of meropenem-vaborbactam (M-V) is non-inferior to piperacillin-tazobactam (P-T), according to a study presented at the annual meeting of the Infectious Diseases Society of America (IDWeek), held from Oct. 26 to 30 in New Orleans.
Jeff Loutit, M.B.Ch.B., of The Medicines Company in San Diego, and colleagues randomized patients to M-V or P-T for 10 days of total therapy. After 15 doses (five days) of intravenous (IV) therapy, patients could be switched to oral levofloxacin if they met prespecified criteria. For inclusion in the study, patients had to have a cUTI or acute pyelonephritis, require IV study antibiotics, and be sick enough to require at least five days of IV therapy.
Overall, success was observed in 98.4 percent of patients receiving M-V and 94.0 percent receiving P-T. Consistent efficacy was also observed for secondary end points and sub-populations. The investigators found that 37 percent of patients had treatment emergent adverse events (TEAEs), 14 percent with drug-related TEAEs, 3.9 percent with discontinuation of study drug due to AEs, and 4.2 percent with serious AEs; 0.7 percent of study participants died. Safety was similar between the groups.
“We improved upon meropenem by adding vaborbactam, a new cyclic boronic acid beta-lactamase inhibitor, which has activity against serine carbapenemases. The focus of our research efforts is to provide a new agent for the treatment of carbapenem-resistant Enterobacteriaceae (CRE),” Loutit told Physician’s Briefing. “We are excited about the results of this trial as we believe M-V has the potential to be an important new drug in the treatment of patients with serious infections due to resistant organisms such as CRE.”
All authors are employees of The Medicines Company, which manufactures meropenem-vaborbactam and funded the study.
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