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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achaogen, Inc.
ClinicalTrials.gov Identifier:
NCT01096849
First received: March 12, 2010
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Complicated Urinary Tract Infection
Acute Pyelonephritis
Drug: levofloxacin
Drug: plazomicin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 or Acute Pyelonephritis

Resource links provided by NLM:


Further study details as provided by Achaogen, Inc.:

Primary Outcome Measures:
  • Microbiological eradication rates in modified intent to treat population and microbiologically evaluable population [ Time Frame: Test of Cure Visit (Day 12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical cure (Investigator's and Sponsor's assessment) [ Time Frame: Throughout the study, up to Day 12 ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: March 2010
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: plazomicin (10 mg/kg)
10 mg/kg intravenous plazomicin daily for 5 consecutive days
Drug: plazomicin
Repeat intravenous infusion
Drug: placebo
Repeat intravenous infusion (used to maintain the blind)
Experimental: plazomicin (15 mg/kg)
15 mg/kg intravenous plazomicin daily for 5 consecutive days
Drug: plazomicin
Repeat intravenous infusion
Drug: placebo
Repeat intravenous infusion (used to maintain the blind)
Active Comparator: levofloxacin
750 mg intravenous levofloxacin daily for 5 consecutive days
Drug: levofloxacin
Repeat intravenous infusion
Drug: placebo
Repeat intravenous infusion (used to maintain the blind)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cUTI/AP with clinical signs and symptoms
  • Normal kidney function

Exclusion Criteria:

  • Patients with any of the following conditions: underlying renal disease (excluding indication cUTI/AP), myasthenia gravis,or other neuromuscular disorder.
  • Urinary tract surgery during the study period.
  • Signs of severe sepsis.
  • Pregnant or breastfeeding women.
  • History of epilepsy or known seizure disorder.
  • Receipt of any investigational medication during the last month prior to randomization.
  • Treatment with another antibiotic within 48 hours prior to randomization.
  • Known history of human immunodeficiency virus (HIV) infection and current or previous CD4 count < 200/mm3.
  • Presence of immunodeficiency or an immunocompromised condition and use of systemic corticosteroids.
  • Presence of neutropenia.
  • History of hearing loss with onset before the age of 40 years.
  • At risk for serious drug interactions because of concomitant medications [e.g., class IA (e.g., quinidine, procainamide, or Class III (e.g, amiodarone, sotalol)antiarrhythmic agents]
  • A QTc (Bazett's)> 440 msec.
  • Known hypersensitivity to other aminoglycosides, levofloxacin, other fluoroquinolone antibiotics.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096849

  Show 31 Study Locations
Sponsors and Collaborators
Achaogen, Inc.
Investigators
Study Director: Medical Director Achaogen, Inc.
  More Information

No publications provided

Responsible Party: Achaogen, Inc.
ClinicalTrials.gov Identifier: NCT01096849     History of Changes
Other Study ID Numbers: ACHN-490-002
Study First Received: March 12, 2010
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Achaogen, Inc.:
urinary tract infection
UTI
cUTI
pyelonephritis
AP
ACHN-490

Additional relevant MeSH terms:
Pyelonephritis
Urinary Tract Infections
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis
Infection
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on July 23, 2014