Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
Purpose
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
Conditions
- Bacteremia
- Staphylococcus Aureus
- Staphylococcus Aureus Bacteremia
- Bacteremia Staph
- Bacteremia Due to Staphylococcus Aureus
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized, double-blind, placebo-controlled
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AP-SA02 |
Anti-staphylococcal bacteriophage |
|
|
Placebo Comparator Placebo |
Inactive isotonic solution |
|
Recruiting Locations
More Details
- NCT ID
- NCT05184764
- Status
- Completed
- Sponsor
- Armata Pharmaceuticals, Inc.
Detailed Description
This study will be conducted in two phases: Phase 1b will to evaluate the safety and tolerability of multiple ascending intravenous (IV) doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) compared to BAT alone in subjects with SA bacteremia (SAB). Phase 2a will evaluate the efficacy, safety, and tolerability of multiple doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated SAB.