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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01096849
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Achaogen, Inc.

Tracking Information
First Submitted Date  ICMJE March 12, 2010
First Posted Date  ICMJE March 31, 2010
Results First Submitted Date  ICMJE July 24, 2018
Results First Posted Date  ICMJE August 22, 2018
Last Update Posted Date August 22, 2018
Actual Study Start Date  ICMJE July 13, 2010
Actual Primary Completion Date April 3, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
  • Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population [ Time Frame: Day 1 to TOC (Day 12) ]
    MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 colony forming unit(s) per milliliter (CFU/mL) were reduced to <10^4 CFU/mL.
  • Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population [ Time Frame: Day 1 to TOC (Day 12) ]
    MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.
  • Percentage of Patients With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Day 1 to the end of study (Day 40) ]
    An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
Microbiological eradication in modified intent to treat population and microbiologically evaluable population [ Time Frame: Test of Cure visit (Day 12) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
  • Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population [ Time Frame: Day 1 to TOC (Day 12) ]
    Investigator's assessment criteria defined Clinical Cure as resolution of baseline clinical signs and symptoms of infection through the TOC visit. The sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered.
  • Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population [ Time Frame: Day 1 to TOC (Day 12) ]
    Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit. The sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered.
  • Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population [ Time Frame: Day 1 to EOT (Day 5) ]
    Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the EOT visit. The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered.
  • Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population [ Time Frame: Day 1 to EOT (Day 5) ]
    MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.
  • Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population [ Time Frame: Day 1 to EOT (Day 5) ]
    MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.
  • Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen [ Time Frame: Day 1 to TOC (Day 12) ]
    MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.
  • Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category [ Time Frame: Day 1 to TOC (Day 12) ]
    MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.
  • Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region [ Time Frame: Day 1 to TOC (Day 12) ]
    MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.
  • Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population [ Time Frame: Day 1 to End of Study (Day 40) ]
    Resolution of clinical signs and symptoms is defined as absence of all signs and symptoms present at baseline.
  • Time (Days) to Clinical Cure Based on Investigator's and Sponsor's Assessments in the MITT Population [ Time Frame: Day 1 to End of Study (Day 40) ]
    Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit. The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered.
  • Time (Days) to Defervescense in the MITT Population [ Time Frame: Day 1 to End of Study (Day 40) ]
    Defervescence is defined as the absence of fever <37.7 degrees Celsius and is assessed in patients who were afebrile at baseline.
  • Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population [ Time Frame: Day 1 to LTFU (Day 40) ]
    Patients who had a clinical relapse (defined as the return of clinical signs and symptoms requiring antibiotic therapy) or microbiological recurrence (defined as eradication of the original pathogen[s] at the TOC visit but regrowth at the level >10^5 CFU/mL by the LTFU [long term follow up] visit).
  • Percentage of Patients With a Superinfection or New Infection in the ME Population [ Time Frame: Day 1 to to End of Study (Day 40) ]
    Superinfections are defined as a pathogen other than the one at baseline found in urine at ≥10^5 CFU/mL any time after the first infusion through EOT. New infections are defined as a pathogen other than the one at baseline found in urine at ≥10^5 CFU/mL any time after EOT.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
Clinical cure (Investigator's and Sponsor's assessment) [ Time Frame: Throughout the study, up to Day 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
Official Title  ICMJE 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
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis
Intervention  ICMJE
  • Drug: levofloxacin
  • Drug: plazomicin
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: plazomicin (10 mg/kg)
    Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo.
    Interventions:
    • Drug: plazomicin
    • Drug: placebo
  • Experimental: plazomicin (15 mg/kg)
    Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
    Interventions:
    • Drug: plazomicin
    • Drug: placebo
  • Active Comparator: levofloxacin
    Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin.
    Interventions:
    • Drug: levofloxacin
    • Drug: placebo
Publications * Connolly LE, Riddle V, Cebrik D, Armstrong ES, Miller LG. A Multicenter, Randomized, Double-Blind, Phase 2 Study of the Efficacy and Safety of Plazomicin Compared with Levofloxacin in the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis. Antimicrob Agents Chemother. 2018 Mar 27;62(4). pii: e01989-17. doi: 10.1128/AAC.01989-17. Print 2018 Apr.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2012)
145
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2010)
225
Actual Study Completion Date  ICMJE April 3, 2012
Actual Primary Completion Date April 3, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Documented or suspected cUTI/AP with clinical signs and symptoms
  • Normal kidney function defined as creatinine clearance (CLcr) of ≥60mL/min using Cockcroft-Gault formula

Key Exclusion Criteria:

  • Acute bacterial prostatis, orchitis, epididymitis, or chronic bacterial prostatis
  • Gross heanaturia requiring intervention other than study drug
  • Urinary tract surgery within 7 days of randomization or during the study period
  • A known nonrenal source of infection diagnosed within 7 days of randomization
  • A corrected QT interval > 440 msec
  • History of hearing loss with onset before the age of 40 years, sensorineural hearing loss, or family history of hearing loss
  • Pregnant or breastfeeding women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Chile,   Colombia,   India,   Mexico,   United States
 
Administrative Information
NCT Number  ICMJE NCT01096849
Other Study ID Numbers  ICMJE ACHN-490-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Achaogen, Inc.
Study Sponsor  ICMJE Achaogen, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Achaogen, Inc.
PRS Account Achaogen, Inc.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP