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

Armata Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Bacteremia Staph; Bacteremia; Staphylococcus Aureus; Bacteremia Due to Staphylococcus Aureus; Staphylococcus Aureus Bacteremia

Treatments: Other: Placebo; Biological: AP-SA02

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT05184764

AP-SA02-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

AP-SA02

Experimental group

Description:

Anti-staphylococcal bacteriophage

Treatment:

Biological: AP-SA02

Placebo

Placebo Comparator group

Description:

Inactive isotonic solution

Treatment:

Other: Placebo