drugset / Trial / NCT01096849

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

NCT01096849

Phase 2 Completed 145 enrolled Achaogen, Inc.
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2010-07-13
Primary completion
2012-04-03
Completion
2012-04-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levofloxacin Small molecule 750 mg Intravenous
Subject plazomicin Small molecule 10 mg/kg Intravenous
Subject plazomicin Small molecule 15 mg/kg Intravenous

Indications