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