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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

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ClinicalTrials.gov Identifier: NCT03148756
Recruitment Status : Terminated (Study stopped due to business reasons.)
First Posted : May 11, 2017
Results First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE May 9, 2017
First Posted Date  ICMJE May 11, 2017
Results First Submitted Date  ICMJE August 8, 2018
Results First Posted Date  ICMJE September 10, 2018
Last Update Posted Date September 10, 2018
Actual Study Start Date  ICMJE May 12, 2017
Actual Primary Completion Date August 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population [ Time Frame: Day 84 ]
Clinical response was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. Failure was defined as: ongoing signs and symptoms considered by the investigator to be related to complicated bacteremia or IE requiring additional antibacterial therapy or unplanned valve replacement, recurrent bacteremia, death during the study period up to Day 84 or discontinuation of the study medication due to an adverse event.
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
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)
Change History Complete list of historical versions of study NCT03148756 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population [ Time Frame: Day 42 ]
    Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
  • Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population [ Time Frame: Day 42 ]
    Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
  • Number of Participants With Day 84 Mortality in the Safety Population [ Time Frame: Day 84 ]
    Day 84 mortality was measured by the number of deaths up to Day 84.
  • Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population [ Time Frame: Day 84 ]
    Clinical outcome was either success or failure/relapse. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
  • Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population [ Time Frame: Day 42 ]
    Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
  • Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population [ Time Frame: Day 84 ]
    Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
  • Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population [ Time Frame: Day 42 ]
    Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
  • Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population [ Time Frame: Day 84 ]
    Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.
  • Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population [ Time Frame: Day 42 ]
    Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
  • Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population [ Time Frame: Day 84 ]
    Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
  • Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population [ Time Frame: Day 42 ]
    Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
  • Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population [ Time Frame: Day 84 ]
    Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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 Bacteremia or Documented Infective Endocarditis
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Endocarditis
  • Bacteremia
Intervention  ICMJE
  • Drug: Dalbavancin
    Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
  • Drug: Standard of Care
    Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Study Arms  ICMJE
  • Experimental: Dalbavancin
    Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
    Intervention: Drug: Dalbavancin
  • Active Comparator: Standard of Care
    Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
    Intervention: Drug: Standard of Care
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 20, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2017)
150
Actual Study Completion Date  ICMJE August 4, 2017
Actual Primary Completion Date August 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A diagnosis of complicated bacteremia or infective endocarditis
  • Gram-positive bacteremia at screening with methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA) or Streptococci
  • Treatment with standard of care antibiotics for 72 hours (h) - 10 days
  • Defervescence for at least 24h and clearance of bacteremia from screening pathogen.

Exclusion Criteria:

  • Embolic events
  • History of prosthetic valve surgery, cardiac device or prosthetic joint
  • Left-sided endocarditis due to Staphylococcus aureus (S. aureus)
  • Large mobile vegetations (>10 mm) on mitral valves
  • Perivalvular abscess
  • Uncomplicated bacteremia due to S. aureus
  • Gram-negative bacteria or fungi in blood cultures
  • Heart failure associated with infective endocarditis [Left Ventricular Ejection Fraction (LVEF) <40%]
  • Intravascular material or removable infection source not intended to be removed within 4 days postrandomization
  • Planned valve replacement surgery within 3 days of randomization
  • Refractory shock, significant hepatic insufficiency or severe leukopenia [Absolute Neutrophil Count (ANC) < 500 cells/mm^3]
  • Known osteomyelitis
  • Hypersensitivity to dalbavancin or other drugs in glycopeptide class
  • Infection with enterococci, coagulase-negative staphylococci, or with organism not susceptible to dalbavancin or vancomycin
  • Immunosuppression/immune deficiency
  • Concomitant systemic antibacterial therapy for gram-positive infection other than that allowed in protocol
  • Pregnant or nursing females.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries Korea, Republic of,   Singapore,   Taiwan,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT03148756
Other Study ID Numbers  ICMJE DAL-MD-09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Urania Rappo, MD Allergan
PRS Account Allergan
Verification Date August 2018

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