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

Phase 2

Terminated

• Conditions: Endocarditis; Bacteremia
• Interventions: Drug: Standard of Care; Drug: Dalbavancin

• Registration Number: NCT03148756
• Lead Sponsor: AbbVie

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Study Start: 2017-05-12
• Primary Completion: 2017-08-04
• Study Completion: 2017-08-04
• Disposition First Submitted: 2018-08-04
• Disposition First Submitted QC: 2018-08-04
• Disposition First Posted: 2018-08-07
• Results First Submitted: 2018-08-08
• Results First Submitted QC: 2018-08-08
• Results First Posted: 2018-09-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Dalbavancin	Dalbavancin	Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population	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

Name	Time	Method
Number of Participants With Day 84 Mortality in the Safety Population	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 42 in the ITT Population	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	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 42 in the ITT Population	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 Microbiological Success by Pathogen at Day 84 in the CE Population	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 Clinical Outcome of Success by Pathogen at Day 42 in the CE Population	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 84 in the CE Population	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 84 in the ITT Population	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 84 in the CE Population	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	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	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	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.

Trial Locations

Locations (1)

Midway Immunology and Research Center; 🇺🇸 Fort Pierce, Florida, United States