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

Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Safety, Tolerability, and Efficacy of Intravenous AP-SA02 as an Adjunct to Best Available Antibiotic Therapy for the Treatment of Adults With Bacteremia Due to Staphylococcus Aureus

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

Study Overview

• Status: Completed
• Conditions: Bacteremia; Staphylococcus Aureus; Staphylococcus Aureus Bacteremia; Bacteremia Due to Staphylococcus Aureus; Bacteremia Staph
• Intervention / Treatment: Biological: AP-SA02; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Royal Adelaide Hospital
  • Clayton, Australia
    • Monash Health
  • Melbourne, Australia
    • Royal Melbourne Hospital
  • Melbourne, Australia
    • The Alfred Hospital
  • Westmead, Australia
    • Westmead Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Banner University Medical Center
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego (UCSD) - Medical Center
    • Los Angeles, California, United States, 90033
      • University of Southern California Keck School of Medicine
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles (UCLA) - Medical Center
    • Torrance, California, United States, 90502
      • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida (UF) - Division of Infectious Disease
    • Jacksonville, Florida, United States, 32209
      • University of Florida - Jacksonville
    • Tampa, Florida, United States, 33620
      • University Of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • New York
    • Jamaica, New York, United States, 11418
      • The Jamaica Hospital Medical Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina - Chapel Hill School of Medicine
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Regional One Healthcare
  • Texas
    • Houston, Texas, United States, 77030
      • Methodist Hospital Research Institute - Houston
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital and the Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2a Complicated SAB - AP-SA02; Anti-staphylococcal bacteriophage	Biological: AP-SA02; Bacteriophage administered via intravenous bolus infusion
Placebo Comparator: Phase 2a Complicated SAB- Placebo; Inactive Isotonic Saline Solution	Other: Placebo; Inactive Placebo administered via intravenous bolus infusion
Experimental: Phase 1b Uncomplicated SAB - AP-SA02; Anti-staphylococcal bacteriophage	Biological: AP-SA02; Bacteriophage administered via intravenous bolus infusion
Placebo Comparator: Phase 1b Uncomplicated SAB - Placebo; Inactive Isotonic Saline Solution	Other: Placebo; Inactive Placebo administered via intravenous bolus infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02.	Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0. Per SAP, all patients with uncomplicated SAB (Phase 1 Cohort 1 and Cohort 2) will be combined.	Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Improvement or Response at Day 12	Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia.	12 Days
Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy as Assessed by the Investigator	Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia.	7 days post completion of best available antibiotic therapy, up to 60 days.
Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy Assessed by the CEAC	Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia.	7 days post completion of best available antibiotic therapy, up to 60 days.
Clinical Improvement or Response as Assessed by the Investigator at 28 Days Post Completion of Best Available Antibiotic Therapy	Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia.	28 days post completion of best available antibiotic therapy, up to 81 days.
Clinical Improvement or Response as Assessed by the CEAC at 28 Days Post Completion of Best Available Antibiotic Therapy	Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia.	28 days post completion of best available antibiotic therapy, up to 81 days.

Collaborators and Investigators

• Sponsor: Armata Pharmaceuticals, Inc.
• Collaborators: United States Department of Defense
• Investigators: Study Director: Deborah Birx, MD, Armata Pharmaceuticals, Inc.

Publications and helpful links

Helpful Links

• Armata Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): November 7, 2024
• Study Completion (Actual): January 14, 2025

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Bacteremia; Staphylococcus Aureus; Staphylococcus; Bacteriophage; Phage; SAB
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pathological Conditions, Signs and Symptoms; Staphylococcal Infections; Bacteremia
• Other Study ID Numbers: AP-SA02-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No