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

NCT05184764 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: AP-SA02-101
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 28

Brief 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

Conditions

Bacteremia; Staphylococcus Aureus; Staphylococcus Aureus Bacteremia; Bacteremia Staph; Bacteremia Due to Staphylococcus Aureus

Keywords

Bacteriophage; Phage; Bacteremia; Staphylococcus Aureus; Staphylococcus; SAB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Clinical Improvement or Response at Day 12

  12 Days

• Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy as Assessed by the Investigator

  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

  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

  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

  28 days post completion of best available antibiotic therapy, up to 81 days.

Study Arms (4)

Phase 2a Complicated SAB - AP-SA02

EXPERIMENTAL

Anti-staphylococcal bacteriophage

Biological: AP-SA02

Phase 2a Complicated SAB- Placebo

PLACEBO COMPARATOR

Inactive Isotonic Saline Solution

Other: Placebo

Phase 1b Uncomplicated SAB - AP-SA02

EXPERIMENTAL

Anti-staphylococcal bacteriophage

Biological: AP-SA02

Phase 1b Uncomplicated SAB - Placebo

PLACEBO COMPARATOR

Inactive Isotonic Saline Solution

Other: Placebo

Interventions

AP-SA02 BIOLOGICAL

Bacteriophage administered via intravenous bolus infusion

Phase 1b Uncomplicated SAB - AP-SA02; Phase 2a Complicated SAB - AP-SA02

Placebo OTHER

Inactive Placebo administered via intravenous bolus infusion

Phase 1b Uncomplicated SAB - Placebo; Phase 2a Complicated SAB- Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armata Pharmaceuticals, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (28)

Banner University Medical Center

Tucson, Arizona, 85719, United States

Location

University of California, San Diego (UCSD) - Medical Center

La Jolla, California, 92037, United States

Location

University of Southern California Keck School of Medicine

Los Angeles, California, 90033, United States

Location

University of California, Los Angeles (UCLA) - Medical Center

Los Angeles, California, 90095, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

University of Florida (UF) - Division of Infectious Disease

Gainesville, Florida, 32610, United States

Location

University of Florida - Jacksonville

Jacksonville, Florida, 32209, United States

Location

University of South Florida

Tampa, Florida, 33620, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

The Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of North Carolina - Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Regional One Healthcare

Memphis, Tennessee, 38103, United States

Location

Methodist Hospital Research Institute - Houston

Houston, Texas, 77030, United States

Location

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Monash Health

Clayton, Australia

Location

Royal Melbourne Hospital

Melbourne, Australia

Location

The Alfred Hospital

Melbourne, Australia

Location

Westmead Hospital

Westmead, Australia

Location

Related Links

• Armata Pharmaceuticals, Inc.

MeSH Terms

Conditions

Bacteremia; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections

Results Point of Contact

• Title: Dr. Deborah Birx
• Organization: Armata Pharmaceuticals

jsmith@armatapharma.com

310-665-2928

Study Officials

• Deborah Birx, MD

  Armata Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 11, 2022
• Study Start: April 26, 2022
• Primary Completion: November 7, 2024
• Study Completion: January 14, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (23); AU (5)