A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

Inclusion Criteria:

- 18 years of age or older with at least one blood culture positive for S. aureus within
48 hours before randomization

- At least one of the following signs or symptoms of bacteremia:

- Temperature ≥ 38.0°C

- WBC count > 10,000 or < 4,000 cells/µL or > 10% immature neutrophils (bands)

- Tachycardia (heart rate > 90 bpm)

- Tachypnea (respiratory rate > 20 breaths/min)

- Hypotension (systolic blood pressure < 90 mmHg)

- Signs or symptoms of localized catheter-related infection

- At enrollment, subjects must have either 1) known right-sided infective endocarditis
by Modified Duke's criteria 2) known complicated bacteremia, demonstrated as signs or
symptoms of metastatic foci of S. aureus infection or 3) at least one risk factor for
complicated bacteremia.

Exclusion Criteria:

- Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for
more than 60 hours within 7 days before randomization. EXCEPTION: Documented
resistance to the prior systemic antibacterial therapy

- Presence of an infection source that will not be managed or controlled within the
first 3 days of study drug treatment

- Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter
defibrillator [ICD]), permanent pacemaker, or cardiac valve support ring)

- Known or suspected left-sided infective endocarditis (LIE), by Modified Duke Criteria.
NOTE: Right-sided infective endocarditis (RIE) is permitted

- Known or suspected osteomyelitis or meningitis. NOTE: Evidence of metastatic
complications related to the primary infection such as right-sided endocarditis,
septic arthritis, septic pulmonary emboli are permitted. S. aureus pneumonia is
permitted

- Confirmed evidence (identification or gram stain) of a mixed polymicrobial infection
with a Gram-negative pathogen that requires non-study antibiotic treatment with
agent(s) that have activity against Gram-negative pathogens