*EOIVT includes patients with organisms resistant to piperacillin/tazobactam at baseline.2,3
†Primary endpoint: 4.1% treatment difference (95% CI, 0.3%&-8.8%) exceeded the lower limit for both noninferiority and superiority.2,3
‡TOC visit excludes patients with organisms resistant to piperacillin/tazobactam at baseline in both arms.2,3
§3.3% treatment difference (95% CI, -6.2%&-13%).2,3
TANGO I Study description
A double-blind, double-dummy, randomized, multicenter noninferiority clinical trial evaluated 545 adult patients with cUTI, including acute pyelonephritis. Patients were treated with VABOMERE (meropenem 2 g/vaborbactam 2 g) or piperacillin/tazobactam (piperacillin 4 g/tazobactam 0.5 g) every 8 hours. After a minimum of 15 doses of IV therapy, patients who met prespecified criteria of improvement could be switched to oral levofloxacin.1,2
Primary endpoint: Overall success at the EOIVT (composite of both a clinical outcome of cure or improvement and a microbiologic outcome of eradication) in the m-MITT population.1,2
Clinical and microbiological response was also assessed at the TOC visit (approximately 7 days after completion of treatment) in the m-MITT population and required both a clinical outcome of cure and a microbiological outcome of eradication.1,2
*Includes patients with organisms resistant to piperacillin/tazobactam at baseline.1
aPiperacillin/tazobactam 4.5 grams (piperacillin 4 g/tazobactam 0.5 g) IV infused over 30 minutes every 8 hours.
bInfusion site reactions include infusion/injection site phlebitis, infusion site thrombosis, and infusion site erythema.
cHypersensitivity includes hypersensitivity, drug hypersensitivity, anaphylactic reaction, rash urticaria, and bronchospasm.
A double-blind, double dummy, randomized, multicenter noninferiority clinical trial evaluated 545 adult patients with cUTI, including acute pyelonephritis. Patients were treated with VABOMERE (meropenem 2 g-vaborbactam 2 g) or piperacillin/tazobactam (piperacillin 4 g/tazobactam 0.5 g) every 8 hours. After a minimum of 15 doses of IV therapy, patients who met prespecified criteria of improvement could be switched to oral levofloxacin.1,2
References: 1. Kaye KS, Bhowmick T, Metallidis S, et al. Effect of meropenem-vaborbactam vs piperacillin-tazobactam on clinical cure or improvement and microbial eradication in complicated urinary tract infection: The TANGO I randomized clinical trial. JAMA. 2018;319(8):788-799. doi:10.1001/jama.2018.0438. 2. Vabomere [package insert]. Melinta Therapeutics, Inc. 3. Data on file: Melinta Therapeutics, Inc. 4. Merrem I.V. [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2014.
VABOMERE® (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs.
The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea.Please see full Prescribing Information.