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 2TerminatedNCT03148756

AbbVie2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Endocarditis Bacteremia

Interventions

DalbavancinDRUG

Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.

Standard of CareDRUG

Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Midway Immunology and Research Center

Ft. Pierce, Florida, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Day 84

Secondary Outcomes

Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population

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.

Time frame: Day 42

Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population

Time frame: Day 42

Number of Participants With Day 84 Mortality in the Safety Population

Day 84 mortality was measured by the number of deaths up to Day 84.

Time frame: Day 84

Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population

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.

Data from ClinicalTrials.gov

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