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

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the maximum safe dose of the true human monoclonal antibody, 514G3, in the treatment of patients with Staphylococcus Aureus bacteremia. Preliminary evidence of efficacy will be evaluated as well. Patients will receive 514G3 plus antibiotics or placebo plus antibiotics in approximately a 3 to 1 ratio.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XBiotech, Inc.
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Antibodies

Criteria

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.