Open
Actively Recruiting
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
About
Brief Summary
Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Escalation Study of the Safety, Tolerability, and Efficacy of Intravenous AP SA02 as an Adjunct to Best Available Antibiotic Therapy Compared to Best Available Antibiotic Therapy Alone for the Treatment of Adults With Bacteremia Due to Staphylococcus aureus
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key Inclusion Criteria:
- A hospitalized female or male ≥ 18 years old
- Positive blood culture for Staphylococcus aureus (SA)
- Source of SA infection controlled, or a plan for source control, if relevant
- Not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if or reproductive potential
Key Exclusion Criteria:
- Concomitant growth of organisms besides SA
- Left-sided infectious endocarditis by modified Duke criteria
- Known or suspected brain abscess or meningitis
- Known allergy to phage products
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Study Stats
Protocol No.
21-002100
Category
Infectious Diseases
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood