A Study of the Safety and Efficacy of 514G3 in Subjects Hospitalized With Bacteremia Due to Staphylococcus Aureus

Inclusion Criteria:

1. One or more blood cultures positive for staphylococcus aureus within 2 days of
initiating treatment with 514G3.

2. Temperature ≥ 38.0°C

3. Age ≥18, male or female subjects.

4. Adequate renal function, defined by serum creatinine ≤ 2 times the upper limit of
normal (ULN).

5. Adequate hepatic function

6. Adequate bone marrow function

7. For women of childbearing potential (WOCBP), a negative serum pregnancy test result
at Screening.

8. Signed and dated institutional review board (IRB)/ Ethics Committee (EC)-approved
informed consent before any protocol-specific screening procedures are performed.

9. Expected survival of at least 2 months.

Exclusion Criteria:

1. Polymicrobial bacteremia.

2. Known or suspected osteomyelitis or meningitis.

3. Patients that are being mechanically ventilated as a result of a pulmonary infection
at the time of screening. Mechanical ventilation for other reasons, such as trauma,
is acceptable.

4. Presence of any removable infection source (e.g., intravascular line, abscess, or
prosthesis) that will not be removed or debrided within 3 days after randomization.

5. Definite or possible left-sided endocarditis, by Modified Duke Criteria, based on
screening echocardiogram. Subjects with suspected right-sided endocarditis are
permitted.

6. Need for emergent valve surgery at the time of screening, and/or the presence of
decompensated heart failure or cardiogenic shock.

7. Dementia or altered mental status that would prohibit the understanding or rendering
of informed consent.

8. Infection with human immunodeficiency virus (HIV) and a CD4 count <200 cells/mm3.

9. Subjects with history of hypersensitivity to compounds of similar chemical or
biologic composition to 514G3 or any component of its formulations.

10. Women who are pregnant or breastfeeding.