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

• Status: Completed
• Trial end date: 2012-04-03
• Target enrollment: 0
• Participant gender: All

Summary

This was a multi-center, multi-national, double-blind, randomized, comparator-controlled study of plazomicin administered intravenously compared with levofloxacin, a standard approved intravenous therapy for complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achaogen, Inc.
• Treatments: Levofloxacin; Ofloxacin

Criteria

Key Inclusion Criteria:

• Documented or suspected cUTI/AP with clinical signs and symptoms

• Normal kidney function defined as creatinine clearance (CLcr) of ≥60mL/min using Cockcroft-Gault formula

Key Exclusion Criteria:

• Acute bacterial prostatis, orchitis, epididymitis, or chronic bacterial prostatis

• Gross heanaturia requiring intervention other than study drug

• Urinary tract surgery within 7 days of randomization or during the study period

• A known nonrenal source of infection diagnosed within 7 days of randomization

• A corrected QT interval > 440 msec

• History of hearing loss with onset before the age of 40 years, sensorineural hearing loss, or family history of hearing loss

• Pregnant or breastfeeding women