Clinical Trial: Study of Plazomicin (ACHN-490) Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind, Randomized, Comparator-controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of ACHN-490 Injection Administered IV in Patients With Complicated Urinary Tract Infections

Brief Summary: 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).

Detailed Summary:
Sponsor: Achaogen, Inc.

Current Primary Outcome: Microbiological eradication rates in modified intent to treat population and microbiologically evaluable population [ Time Frame: Test of Cure Visit (Day 12) ]

Original Primary Outcome: Microbiological eradication in modified intent to treat population and microbiologically evaluable population [ Time Frame: Test of Cure Visit (Day 12) ]

Current Secondary Outcome: Clinical cure (Investigator's and Sponsor's assessment) [ Time Frame: Throughout the study, up to Day 12 ]

Original Secondary Outcome: Same as current

Information By: Achaogen, Inc.

Dates:
Date Received: March 12, 2010
Date Started: March 2010
Date Completion:
Last Updated: July 9, 2013
Last Verified: July 2013