Bacteremia Clinical Trial
Official title:
A Phase 3, Multi-Center, Randomized, Open-Label Study of Vabomere(Meropenem-vaborbactam) Versus Best Available Therapy in Subjects With Selected Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
Vabomere™, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
In the current era of increased resistance to extended spectrum cephalosporins and
penicillin/beta-lactamase inhibitor combinations, carbapenem antimicrobial agents are
frequently the antibiotics of "last defense" for the most resistant pathogens in serious
infections. However, the recent dissemination of serine carbapenemases (e.g. KPC) in
Enterobacteriaceae within many hospitals worldwide now poses a considerable threat to
carbapenems and other members of the beta-lactam class of antimicrobial agents.
Infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) are associated with high
mortality rates and have limited treatment options. The loss of the carbapenem class of
antimicrobial agents for treatment of Enterobacteriaceae (the most frequently occurring
pathogens in the hospital setting), Acinetobacter baumannii, and Pseudomonas aeruginosa
represents a critical setback in modern patient care.
As a result of the current lack of an optimal treatment for patients who have infections due
to a CRE, physicians manage these patients with the limited anti-infective options available,
including aminoglycosides, polymyxin B, colistin, tigecycline, or various combinations of
these. There are limited efficacy data available for many of these therapies when used to
treat serious CRE infections, particularly in combination, but with limited or no alternative
therapies currently available, such treatments have become the Best Available Therapy despite
the toxicities associated with many of them.
Vaborbactam is a novel beta-lactamase inhibitor that has inhibitory activity against many
serine beta-lactamases and was optimized for inhibition of the KPC beta-lactamase and the
potentiation of carbapenems against Enterobacteriaceae. Vaborbactam is being developed for
use with meropenem (a broad spectrum injectable carbapenem antibiotic) to address the
challenges of treatment of serious infections caused by pathogens increasingly resistant to
available treatments.
Vabomere, (meropenem-vaborbactam) administered as a fixed combination by intravenous (IV)
infusion, is being developed to treat serious gram-negative infections, such as complicated
urinary tract infections (cUTI), acute pyelonephritis (AP), hospital-acquired bacterial
pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and bacteremia, including
those infections caused by bacteria resistant to currently available carbapenems.
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