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

March 3, 2026 updated by: Armata Pharmaceuticals, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02.
Time Frame: Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Improvement or Response at Day 12
Time Frame: 12 Days
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
Time Frame: 7 days post completion of best available antibiotic therapy, up to 60 days.
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
Time Frame: 7 days post completion of best available antibiotic therapy, up to 60 days.
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
Time Frame: 28 days post completion of best available antibiotic therapy, up to 81 days.
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
Time Frame: 28 days post completion of best available antibiotic therapy, up to 81 days.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Armata Pharmaceuticals, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Deborah Birx, MD, Armata Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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