Phase 2
N=56
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
Bacteremia · Staphylococcus Aureus · Staphylococcus Aureus Bacteremia · Bacteremia Staph · Bacteremia Due to Staphylococcus Aureus
Bottom Line
View on ClinicalTrials.gov: NCT05184764 ↗Enrolled (actual)
56
Serious AEs
26.0%
Results posted
Mar 2026
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02. — 17; 10; 6; 2 number of participants — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AP-SA02 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Armata Pharmaceuticals, Inc.
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02. |
17; 10; 6; 2 | 0.25 |
| SECONDARY Clinical Improvement or Response at Day 12 |
21; 7; 20; 7 | — |
| SECONDARY Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy as Assessed by the Investigator |
21; 6 | — |
| SECONDARY Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy Assessed by the CEAC |
21; 7 | — |
| SECONDARY Clinical Improvement or Response as Assessed by the Investigator at 28 Days Post Completion of Best Available Antibiotic Therapy |
21; 6 | — |
| SECONDARY Clinical Improvement or Response as Assessed by the CEAC at 28 Days Post Completion of Best Available Antibiotic Therapy |
20; 6 | — |
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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT05184764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.