Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP

Phase 3 Completed 550 enrolled Melinta Therapeutics, Inc. Department of Health and Human Services · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).

Timeline

Start: 2014-11-20
Primary completion: 2016-04-28
Completion: 2016-04-28

Outcome

Met primary endpoint

paper difference, 4.5% [95% CI, 0.7% to 9.1%]; P < .001 for noninferiority. PMID 29486041 ↗

paper difference, 9.0% [95% CI, -0.9% to 18.7%]; P < .001 for noninferiority PMID 29486041 ↗

paper difference, 5.9% [95% CI, -4.2% to 16.0%]; P < .001 for noninferiority. PMID 29486041 ↗

Publications

Kaye KS, Bhowmick T, Metallidis S, Bleasdale SC, Sagan OS, Stus V, Vazquez J, Zaitsev V, Bidair M, Chorvat E, Dragoescu PO, Fedosiuk E, Horcajada JP, Murta C, Sarychev Y, Stoev V, Morgan E, Fusaro K, Griffith D, Lomovskaya O, Alexander EL, Loutit J, Dudley MN, Giamarellos-Bourboulis EJ. 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 Feb 27;319(8):788-799. doi: 10.1001/jama.2018.0438.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Meropenem	Small molecule	2 g	Intravenous
Comparator	Piperacillin	Small molecule	4 g	Intravenous
Comparator	Tazobactam	Small molecule	0.5 g	Intravenous
Subject	Vaborbactam	Small molecule	2 g	Intravenous
Background	Levofloxacin	Small molecule	500 mg	Oral