Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia

ID#: NCT05184764

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1/Phase 2

Recruitment Status: Recruiting

Start Date: April 26, 2022

End Date: December 01, 2023

Contact Information:
Thomas Feinberg
Pierre Kyme, PhD
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
Eligibility: 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