Clinical Trial: Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

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

Official Title: A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including

Brief Summary: This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

Detailed Summary: Approximately 500 subjects will be enrolled into this study and randomized 1:1 to receive CXA-201 or comparator (levofloxacin) resulting in 250 subjects per treatment arm. Subject participation will require a minimum commitment of 35 days and a maximum of 42 days. Subjects will be hospitalized for the administration of all doses of IV study therapy. A test of cure visit will occur at 7 days after the last dose of study drug and a late follow-up evaluation or contact will occur a minimum of 28 days and a maximum of 35 days after the last dose of study drug.
Sponsor: Cubist Pharmaceuticals LLC

Current Primary Outcome: The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population [ Time Frame: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration) ]

Original Primary Outcome: The proportion of subjects (CXA 201 versus levofloxacin) who have both a per-subject microbiological outcome of eradication and a clinical outcome of cure in the mMITT population at the TOC. [ Time Frame: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration) ]

The primary efficacy outcome measure is the composite microbiological eradication and clinical cure rate, which is defined as the proportion of subjects (CXA 201 versus levofloxacin) who have both a per-subject microbiological outcome of eradication and a clinical outcome of cure in the mMITT population at the TOC.


Current Secondary Outcome: The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population. [ Time Frame: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration) ]

Original Secondary Outcome:

  • The proportion of subjects (CXA 201 versus levofloxacin) who have both a per-subject microbiological outcome of eradication and a clinical outcome of cure in the ME at TOC population at the TOC visit. [ Time Frame: Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration) ]
    The composite microbiological eradication and clinical cure rate, which is defined as the proportion of subjects (CXA 201 versus levofloxacin) who have both a per-subject microbiological outcome of eradication and a clinical outcome of cure in the ME at TOC population at the TOC visit will be calculated.
  • The number and percentage of subjects in each treatment group recorded as a clinical cure or failure or indeterminate. [ Time Frame: Multiple visits up until the Late Follow Up (28-35 Days after completion of study drug administration) ]
    Clinical response CXA 201 versus comparator (levofloxacin) at the end of therapy (EOT), test-of-cure (TOC), and late follow up (LFU; 28 35 days post last dose of study drug) visits.
  • The number and percentage of subjects in each treatment group recorded as a microbiological eradication or persistence or indeterminate. [ Time Frame: Multiple visits up until the Late Follow Up (28-35 Days after completion of study drug administration) ]
    Microbiological response of CXA 201 versus comparator (levofloxacin) at the end of therapy (EOT), test-of-cure (TOC), and late follow up (LFU; 28-35 days post last dose of study drug) visits
  • For each unique pathogen, the number and percentage of subjects in each treatment group recorded as a microbiologic eradication or persistence for that particular pathogen. [ Time Frame: Late Follow Up (28-35 Days after completion of study drug administration) ]
    Per-pathogen microbiological eradication rates
  • Safety will be evaluated in the safety population by presenting summaries of AEs, laboratory evaluations (coagulation, hematology, chemistry evaluations, and urinalysis), vital signs, and physical examinations in the 2 treatment groups. [ Time Frame: All study visits through the Late Follow Up (28-35 Days after completion of study drug administration) ]

    Safety will be evaluated in the safety population through review of summaries of :

    • AEs
    • Laboratory evaluations
    • Vital signs
    • Physical examinations


Information By: Cubist Pharmaceuticals LLC

Dates:
Date Received: April 28, 2011
Date Started: June 1, 2011
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017