Clinical Trial: Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase 2, Open-Label, Randomized, Multicenter Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated

Brief Summary: This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the completion of therapy in patients with complicated bacteremia or infective endocarditis.

Detailed Summary:
Sponsor: Allergan

Current Primary Outcome: Clinical response at Day 84 in the ITT population [ Time Frame: At Day 84 ]

Clinical response can be either success or failure. Success is defined as recovery without need for additional antibiotic therapy.

Failure is defined as:

  • requirement of additional antibiotic therapy
  • recurrent bacteremia
  • death up to Day 84
  • discontinuation of study drug due to adverse event (AE)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical outcome at Day 42 in the ITT and the CE populations [ Time Frame: At Day 42 ]

    Clinical outcome can be either Success or Failure. Success is defined as recovery without need for additional antibiotic therapy.

    Failure is defined as:

    • requirement of additional antibiotic therapy
    • recurrent bacteremia
    • death up to Day 42
  • Day 84 mortality in the safety population [ Time Frame: At Day 84 ]
    Day 84 mortality is measured by the number of deaths up to Day 84.
  • Clinical outcome at Day 84 in the CE population [ Time Frame: At Day 84 ]

    Clinical outcome can be either Success or Failure/Relapse. Success is defined as recovery without need for additional antibiotic therapy.

    Failure/Relapse is defined as:

    • requirement of additional antibiotic therapy
    • new signs and symptoms after recovery at Day 42
    • recurrent bacteremia
    • patient considered as clinical failure at Day 42
    • death up to Day 84
  • Clinical outcome by pathogen at Day 42 and Day 84 in the ITT and CE populations [ Time Frame: At Day 42 and Day 84 ]

    Clinical outcome by pathogen at Day 42 can be either Success or Failure. Success is defined as recovery without need for additional antibiotic therapy.

    Failure is defined as:

    • requirement of additional antibiotic therapy
    • recurrent bacteremia
    • death up to Day 42

    Clinical outcome by pathogen at Day 84 can be either Success or Failure/Relapse.

    Success is defined as recovery without need for additional antibiotic therapy.

    Failure/Relapse is defined as:

    • requirement of additional antibiotic therapy
    • new signs and symptoms after recovery at Day 42
    • recurrent bacteremia
    • patient defined as clinical failure at Day 42
    • death up to Day 84
  • Microbiologic outcome by pathogen at Day 42 and Day 84 in the ITT and CE populations [ Time Frame: At Day 42 and Day 84 ]

    Microbiological outcome can be either Microbiologic Success or Microbiologic Failure.

    Microbiologic Success is defined as no further growth of baseline pathogen from blood cultures.

    Microbiologic Failure is defined as:

    • further growth of baseline pathogen from 2 consecutive blood cultures leading to the discontinuation of study drug
    • isolation of the baseline pathogen from 2 consecutive blood cultures after initial clinical improvement (relapse)


Original Secondary Outcome: Same as current

Information By: Allergan

Dates:
Date Received: May 9, 2017
Date Started: May 11, 2017
Date Completion: November 21, 2018
Last Updated: May 9, 2017
Last Verified: May 2017