A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)

Phase 3 Completed 609 enrolled Achaogen, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This was a randomized, multicenter, multinational, double-blind study comparing the efficacy and safety of plazomicin compared with meropenem followed by optional oral (PO) therapy in the treatment of cUTI, including AP, in adults.

Timeline

Start: 2016-01-11
Primary completion: 2016-09-22
Completion: 2016-09-22

Outcome

Met primary endpoint

paper Plazomicin was noninferior to meropenem with respect to the primary efficacy end points. PMID 30786187 ↗

registry analysis (non-inferiority test); Plazomicin vs Meropenem; Difference -3.4 (95% CI -10 to 3.1) NCT02486627 ↗

registry analysis (non-inferiority test); Plazomicin vs Meropenem; Difference 11.6 (95% CI 2.7 to 20.3) NCT02486627 ↗

Publications

Wagenlehner FME, Cloutier DJ, Komirenko AS, Cebrik DS, Krause KM, Keepers TR, Connolly LE, Miller LG, Friedland I, Dwyer JP; EPIC Study Group. Once-Daily Plazomicin for Complicated Urinary Tract Infections. N Engl J Med. 2019 Feb 21;380(8):729-740. doi: 10.1056/NEJMoa1801467.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Meropenem	Small molecule	1 g	Intravenous
Subject	plazomicin	Small molecule	15 mg/kg	Intravenous
Background	Levofloxacin	Small molecule	250 mg	Oral
Background	Levofloxacin	Small molecule	500 mg	Oral