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

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.