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CompletedNCT05184764diSArmUpdated Mar 23, 2026Results posted

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

A Phase 1/2 interventional study of AP-SA02 and Placebo in Bacteremia, Staphylococcus Aureus and Staphylococcus Aureus Bacteremia, sponsored by Armata Pharmaceuticals, Inc.. Completed at 28 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Armata Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Bacteremia
  • Staphylococcus Aureus
  • Staphylococcus Aureus Bacteremia
  • Bacteremia Staph
  • Bacteremia Due to Staphylococcus Aureus

Keywords

  • Bacteriophage
  • Phage
  • Bacteremia
  • Staphylococcus Aureus
  • Staphylococcus
  • SAB
03

In context

Bacteremia

322 studies on the registry are indexed under Bacteremia; 49 are open to participants now.

This study's enrollment of 56 is below the median of 149 across 171 interventional studies indexed under Bacteremia.

Browse Bacteremia studies →

Lead sponsor

Armata Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Phase 2a Complicated SAB - AP-SA02

    Anti-staphylococcal bacteriophage

    Biological: AP-SA02

  • Placebo comparator
    Phase 2a Complicated SAB- Placebo

    Inactive Isotonic Saline Solution

    Other: Placebo

  • Experimental
    Phase 1b Uncomplicated SAB - AP-SA02

    Anti-staphylococcal bacteriophage

    Biological: AP-SA02

  • Placebo comparator
    Phase 1b Uncomplicated SAB - Placebo

    Inactive Isotonic Saline Solution

    Other: Placebo

Interventions

  • BiologicalAP-SA02

    Bacteriophage administered via intravenous bolus infusion

  • OtherPlacebo

    Inactive Placebo administered via intravenous bolus infusion

06

What researchers measure

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.

    Time frame: Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81).

Secondary outcomes

  1. 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.

    Time frame: 12 Days

  2. 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.

    Time frame: 7 days post completion of best available antibiotic therapy, up to 60 days.

  3. 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.

    Time frame: 7 days post completion of best available antibiotic therapy, up to 60 days.

  4. 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.

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

  5. 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.

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

07

Results

Posted Mar 23, 2026

Participant flow

Participant flow — Overall Study
MilestoneAP-SA02 Phase 1 Cohort 1 UncomplicatedPlacebo Phase 1 Cohort 1 UncomplicatedAP-SA02 Phase 1 Cohort 2 UncomplicatedPlacebo Phase 1 Cohort 2 UncomplicatedAP-SA02 Phase 2 ComplicatedPlacebo Phase 2 Complicated
Started41313116
Completed2131218
Not completed2000108

Outcome measures

SecondaryClinical 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.

Time frame:
12 Days
Reported as:
Number · Participants
Clinical Improvement or Response at Day 12
ParticipantsAP-SA02 Phase 2 ComplicatedPlacebo Phase 2 Complicated
Clinical Response Assessed by the Investigator217
Clinical Response Assessed by the CEAC207
PrimaryNumber 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.

Time frame:
Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81).
Reported as:
Number · number of participants
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02.
number of participantsPhase 2a Complicated SAB - AP-SA02 + Best Available Antibiotic Therapy (BAT)Phase 2a Complicated SAB - Placebo + Best Available Antibiotic Therapy (BAT)Phase 1b Uncomplicated SAB - AP-SA02 + Best Available Antibiotic Therapy (BAT)Phase 1b Uncomplicated SAB - Placebo + Best Available Antibiotic Therapy (BAT)
≥ 1 TEAE n (%)171062
Statistical analysis
  • Phase 2a Complicated SAB - AP-SA02 + Best Available Antibiotic Therapy (BAT) vs Phase 2a Complicated SAB - Placebo + Best Available Antibiotic Therapy (BAT) vs Phase 1b Uncomplicated SAB - AP-SA02 + Best Available Antibiotic Therapy (BAT) vs Phase 1b Uncomplicated SAB - Placebo + Best Available Antibiotic Therapy (BAT) · Chi-squared · p = 0.25
SecondaryClinical 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.

Time frame:
7 days post completion of best available antibiotic therapy, up to 60 days.
Reported as:
Number · Participants
Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy as Assessed by the Investigator
ParticipantsAP-SA02 Phase 2 ComplicatedPlacebo Phase 2 Complicated
Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy as Assessed by the Investigator216
SecondaryClinical 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.

Time frame:
7 days post completion of best available antibiotic therapy, up to 60 days.
Reported as:
Number · Participants
Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy Assessed by the CEAC
ParticipantsAP-SA02 Phase 2 ComplicatedPlacebo Phase 2 Complicated
Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy Assessed by the CEAC217
SecondaryClinical 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.

Time frame:
28 days post completion of best available antibiotic therapy, up to 81 days.
Reported as:
Number · Participants
Clinical Improvement or Response as Assessed by the Investigator at 28 Days Post Completion of Best Available Antibiotic Therapy
ParticipantsAP-SA02 Phase 2 ComplicatedPlacebo Phase 2 Complicated
Clinical Improvement or Response as Assessed by the Investigator at 28 Days Post Completion of Best Available Antibiotic Therapy216
SecondaryClinical 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.

Time frame:
28 days post completion of best available antibiotic therapy, up to 81 days.
Reported as:
Number · Participants
Clinical Improvement or Response as Assessed by the CEAC at 28 Days Post Completion of Best Available Antibiotic Therapy
ParticipantsAP-SA02 Phase 2 ComplicatedPlacebo Phase 2 Complicated
Clinical Improvement or Response as Assessed by the CEAC at 28 Days Post Completion of Best Available Antibiotic Therapy206

Adverse events

Collected over Time period is through EOS (Day 39-81).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AP-SA02 Phase 2 Complicated1/29 (3.4%)4/29 (13.8%)19/29 (65.5%)
Placebo Phase 2 Complicated0/13 (0%)3/13 (23.1%)12/13 (92.3%)
AP-SA02 Phase 1 Cohort 1 Uncomplicated0/3 (0%)3/3 (100%)3/3 (100%)
AP-SA02 Phase 1 Cohort 2 Uncomplicated0/3 (0%)2/3 (66.7%)2/3 (66.7%)
Placebo Phase 1 Cohort 1 Uncomplicated0/1 (0%)1/1 (100%)1/1 (100%)
Placebo Phase 1 Cohort 2 Uncomplicated0/1 (0%)0/1 (0%)1/1 (100%)
Most frequent serious events
Most frequent serious events
EventAP-SA02 Phase 2 ComplicatedPlacebo Phase 2 ComplicatedAP-SA02 Phase 1 Cohort 1 UncomplicatedAP-SA02 Phase 1 Cohort 2 UncomplicatedPlacebo Phase 1 Cohort 1 UncomplicatedPlacebo Phase 1 Cohort 2 Uncomplicated
Cardiac DisordersCardiac disorders1/293/130/31/31/10/1
Gastrointestinal DisordersGastrointestinal disorders1/293/131/30/30/10/1
General DisordersGeneral disorders1/290/130/31/30/10/1
Infections and InfestationsMetabolism and nutrition disorders1/292/131/30/30/10/1
Nervous System DisordersNervous system disorders0/291/131/30/30/10/1
Respiratory Thoracic and MediastinalRespiratory, thoracic and mediastinal disorders1/290/130/31/30/10/1
Immune System DisordersImmune system disorders0/291/130/30/30/10/1
Metabolism and Nutrition DisordersMetabolism and nutrition disorders0/291/130/30/30/10/1
Renal and Urinary DisordersRenal and urinary disorders1/290/130/30/30/10/1
Vascular DisordersVascular disorders0/290/130/30/30/10/1
Most frequent other events
Showing 10 of 85
Most frequent other events
EventAP-SA02 Phase 2 ComplicatedPlacebo Phase 2 ComplicatedAP-SA02 Phase 1 Cohort 1 UncomplicatedAP-SA02 Phase 1 Cohort 2 UncomplicatedPlacebo Phase 1 Cohort 1 UncomplicatedPlacebo Phase 1 Cohort 2 Uncomplicated
Abscess LimbInfections and infestations0/290/130/30/30/11/1
HyperkalaemiaMetabolism and nutrition disorders0/291/130/30/31/10/1
HypersensitivityImmune system disorders0/290/131/30/30/10/1
Abscess Soft TissueInfections and infestations0/290/131/30/30/10/1
Arthritis BacterialInfections and infestations1/290/131/30/30/10/1
Skin InfectionInfections and infestations0/290/130/31/30/10/1
Blood Creatinine IncreasedInvestigations0/290/131/30/30/10/1
HypoglycaemiaMetabolism and nutrition disorders0/290/131/30/30/10/1
HypokalaemiaMetabolism and nutrition disorders1/291/131/30/30/10/1
EpistaxisRespiratory, thoracic and mediastinal disorders0/291/131/30/30/10/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)AP-SA02 Phase 2 ComplicatedPlacebo Phase 2 ComplicatedPlacebo Phase 1 Cohort 1 UncomplicatedPlacebo Phase 1 Cohort 2 UncomplicatedAP-SA02 Phase 1 Cohort 1 UncomplicatedAP-SA02 Phase 1 Cohort 2 UncomplicatedTotal
<=18 years0000000
Between 18 and 65 years2312113343
>=65 years84001013
Sex: Female, Male
Sex: Female, Male(Participants)AP-SA02 Phase 2 ComplicatedPlacebo Phase 2 ComplicatedPlacebo Phase 1 Cohort 1 UncomplicatedPlacebo Phase 1 Cohort 2 UncomplicatedAP-SA02 Phase 1 Cohort 1 UncomplicatedAP-SA02 Phase 1 Cohort 2 UncomplicatedTotal
Female96001117
Male2210113239
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AP-SA02 Phase 2 ComplicatedPlacebo Phase 2 ComplicatedPlacebo Phase 1 Cohort 1 UncomplicatedPlacebo Phase 1 Cohort 2 UncomplicatedAP-SA02 Phase 1 Cohort 1 UncomplicatedAP-SA02 Phase 1 Cohort 2 UncomplicatedTotal
Hispanic or Latino135012122
Not Hispanic or Latino1811102234
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(participants)AP-SA02 Phase 2 ComplicatedPlacebo Phase 2 ComplicatedPlacebo Phase 1 Cohort 1 UncomplicatedPlacebo Phase 1 Cohort 2 UncomplicatedAP-SA02 Phase 1 Cohort 1 UncomplicatedAP-SA02 Phase 1 Cohort 2 UncomplicatedTotal
United States3016114355
Australia1000001
08

Study locations

28 sites
  • Banner University Medical Center
    Tucson, Arizona 85719, United States
  • University of California, San Diego (UCSD) - Medical Center
    La Jolla, California 92037, United States
  • University of Southern California Keck School of Medicine
    Los Angeles, California 90033, United States
  • University of California, Los Angeles (UCLA) - Medical Center
    Los Angeles, California 90095, United States
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
    Torrance, California 90502, United States
  • Rocky Mountain Regional VA Medical Center
    Aurora, Colorado 80045, United States
  • University of Florida (UF) - Division of Infectious Disease
    Gainesville, Florida 32610, United States
  • University of Florida - Jacksonville
    Jacksonville, Florida 32209, United States
  • University of South Florida
    Tampa, Florida 33620, United States
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
  • Johns Hopkins University
    Baltimore, Maryland 21218, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • University of Michigan
    Ann Arbor, Michigan 48103, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • The Jamaica Hospital Medical Center
    Jamaica, New York 11418, United States
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
  • University of North Carolina - Chapel Hill School of Medicine
    Chapel Hill, North Carolina 27599, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
  • Regional One Healthcare
    Memphis, Tennessee 38103, United States
  • Methodist Hospital Research Institute - Houston
    Houston, Texas 77030, United States
  • Froedtert Hospital and the Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • Royal Adelaide Hospital
    Adelaide, Australia
  • Monash Health
    Clayton, Australia
  • Royal Melbourne Hospital
    Melbourne, Australia
  • The Alfred Hospital
    Melbourne, Australia
  • Westmead Hospital
    Westmead, Australia
09

References and documents

Study documents

  • Study protocol · Jul 25, 2024
  • Statistical analysis plan · Aug 26, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05184764
Lead sponsor
Armata Pharmaceuticals, Inc.
Collaborators
United States Department of Defense
Responsible party
Sponsor
First posted
Jan 11, 2022
Start date
Apr 26, 2022
Primary completion
Nov 7, 2024
Completion
Jan 14, 2025
Results posted
Mar 23, 2026
Last update
Mar 23, 2026

Study contacts

Deborah Birx, MD
study director · Armata Pharmaceuticals, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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