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
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 April 17, 2014