MedTrace Logo

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

NCT01096849 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2018-08-22

Study results available
· View outcomes & findings →

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).

Conditions

  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis

Interventions

DRUG

levofloxacin

DRUG

plazomicin

DRUG

placebo

Sponsors & Collaborators

  • Achaogen, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Achaogen, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096849 on ClinicalTrials.gov