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 in New Orleans.1
Jeff Loutit, MBChB, 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 (5 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 5 days of IV therapy.
Overall, success was observed in 98.4% of patients receiving M-V and 94% receiving P-T. Consistent efficacy was also observed for secondary end points and sub-populations. The investigators found that 37% of patients had treatment emergent adverse events (TEAEs), 14% with drug-related TEAEs, 3.9% with discontinuation of study drug due to AEs, and 4.2% with serious AEs; 0.7% 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.
- Meropenem-vaborbactam (M-V) compared with piperacillin-tazobactam (P-T) in the treatment of adults with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP) in a phase 3 randomized, double-blind, double-dummy trial. Abstract no, LB-7. Presented at: IDWeek 2016; October 26-31, 2016; New Orleans, LA.