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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
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment Phase
Infective Endocarditis, Bacteremia Drug: Dalbavancin Drug: Standard of Care Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Bacteremia or Documented Infective Endocarditis
Actual Study Start Date : May 12, 2017
Actual Primary Completion Date : August 4, 2017
Actual Study Completion Date : August 4, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dalbavancin

Arm Intervention/treatment
Experimental: Dalbavancin
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8
Drug: Dalbavancin
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8

Active Comparator: Standard of Care
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks
Drug: Standard of Care
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of complicated bacteremia or infective endocarditis
  • Gram-positive bacteremia at screening with MSSA, MRSA or Streptococci
  • Treatment with standard of care antibiotics for 72 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 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 endocarditis (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 (ANC < 500 cells/mm3)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148756


Locations
United States, Florida
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
United States, Georgia
Infectious Disease Specialists of ATL, PC
Decatur, Georgia, United States, 30033
United States, Kansas
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States, 66160
Infectious Disease Consultants
Wichita, Kansas, United States, 67214
United States, Louisiana
Ochsner Health System
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Institute for Human Performance
Syracuse, New York, United States, 13210
Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of, 02841
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Singapore
National Heart Centre of Singapore Pte Ltd
Singapore, Singapore, 168753
Singapore General Hospital
Singapore, Singapore, 168753
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 81362
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Tri-Service General Hospital
Taipei, Taiwan, 114
United Kingdom
Birmingham Heart of England NHS Foundation Trust
Birmingham, United Kingdom, B9 5SS
Addenbrook's Hospital Dept of Infectious Disease
Cambridge, United Kingdom, CB2 OQQ
Oxford University Hospitals, NHS Trust
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Allergan
Investigators
Study Director: Urania Rappo, M.D. Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03148756     History of Changes
Other Study ID Numbers: DAL-MD-09
2016-004170-17 ( EudraCT Number )
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Bacterial Infections
Infection
Cardiovascular Infections
Anti-Bacterial Agents
Bacteremia
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Dalbavancin
Teicoplanin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents