Phase III trial suggests meropenem–vaborbactam a valuable option for CRE infection

A Phase III, multinational, open-label, randomized controlled trial (TANGO II) has suggested that meropenem–vaborbactam monotherapy could be a valuable new treatment option for carbapenem-resistant Enterobacteriaceae (CRE) infections, with increased clinical cure, decreased mortality, and reduced nephrotoxicity compared with the best-available therapy (BAT).

Treatment options for CRE are limited, with infections associated with high clinical failure and mortality rates. The TANGO II study therefore aimed to evaluate the efficacy and safety of meropenem–vaborbactam monotherapy versus BAT for CRE.

The team enrolled 77 patients with confirmed/suspected CRE infection between 2014 and 2017, randomizing them 2:1 to meropenem–vaborbactam (2 g/2 g over 3 h, q8h for 7–14 days) or BAT (mono/combination therapy with polymyxins, carbapenems, aminoglycosides, tigecycline; or ceftazidime-avibactam alone).

Of the eligible patients, it was observed that meropenem–vaborbactam was associated with higher rates of clinical cure than BAT. This increased cure rate was demonstrated even in immunocompromised patients – a group typically excluded from clinical trials but at high risk of such infections.

In addition, meropenem–vaborbactam was associated with reduced all-cause mortality. Day-28 all-cause mortality was numerically lower with meropenem–vaborbactam versus BAT [15.6% vs. 33.3%).

TANGO II is the first prospective, Phase III, comparative trial of monotherapy with a novel agent in patients with CRE infections. Moreover, the participants included patients with multiple comorbidities, underlying immunocompromise, and moderate-to-severe renal impairment – a rarity in clinical trials.

Despite being the largest trial to date specifically for CRE, the researchers note that TANGO II does have a small sample size. However, regardless of this, meropenem–vaborbactam appears to be a valuable new addition to the treatment options against CRE pathogens.

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Source: Wunderink RG, Giamarellos-Bourboulis EJ, Rahav G et al. Effect and safety of meropenem–vaborbactam versus best-available therapy in patients with carbapenem-resistant Enterobacteriaceae infections: The TANGO II randomized clinical trial. Infect. Dis Ther. doi:10.1007/s40121-018-0214-1 (2018).


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