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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

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
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: Single (Outcomes Assessor)
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. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.



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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 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.

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
Sponsors and Collaborators
Allergan
Investigators
Study Director: Urania Rappo, MD Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03148756     History of Changes
Other Study ID Numbers: DAL-MD-09
First Posted: May 11, 2017    Key Record Dates
Results First Posted: September 10, 2018
Last Update Posted: September 10, 2018
Last Verified: August 2018

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