BacteremiaPhase 1/2diSArmNCT05184764
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
A Phase 1/2 study testing AP-SA02 in people with Bacteremia and Staphylococcus Aureus, run by Armata Pharmaceuticals, Inc. at 28 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia
- What is being tested?
- AP-SA02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 28 sitesin 2 countries
- Study dates
- 26 Apr 2022to 14 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48103
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21218
Tufts Medical Center
Boston, Massachusetts, 02111
University of North Carolina - Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599
Henry Ford Health System
Detroit, Michigan, 48202
University of Florida (UF) - Division of Infectious Disease
Gainesville, Florida, 32610
Methodist Hospital Research Institute - Houston
Houston, Texas, 77030
University of Florida - Jacksonville
Jacksonville, Florida, 32209
The Jamaica Hospital Medical Center
Jamaica, New York, 11418
University of California, San Diego (UCSD) - Medical Center
La Jolla, California, 92037
University of Southern California Keck School of Medicine
Los Angeles, California, 90033
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, 90095
Regional One Healthcare
Memphis, Tennessee, 38103
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Rhode Island Hospital
Providence, Rhode Island, 02903
University of South Florida
Tampa, Florida, 33620
Montefiore Medical Center
The Bronx, New York, 10467
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, 90502
Banner University Medical Center
Tucson, Arizona, 85719
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Australia5 sites
Royal Adelaide Hospital
Adelaide
Monash Health
Clayton
Royal Melbourne Hospital
Melbourne
The Alfred Hospital
Melbourne
Westmead Hospital
Westmead
About this study
Official title: 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
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.
- Conditions
- Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia, Bacteremia Staph, Bacteremia Due to Staphylococcus Aureus
- Being tested
- AP-SA02, Placebo
- Keywords
- Bacteriophage, Phage, Bacteremia, Staphylococcus Aureus, Staphylococcus, SAB
- Medical subject headings
- Bacteremia, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP-SA02Biological
Bacteriophage administered via intravenous bolus infusion
PlaceboOther
Inactive Placebo administered via intravenous bolus infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 2a Complicated SAB - AP-SA02 | Experimental | Anti-staphylococcal bacteriophage Receives: Biological: AP-SA02 |
| Phase 2a Complicated SAB- Placebo | Placebo comparator | Inactive Isotonic Saline Solution Receives: Other: Placebo |
| Phase 1b Uncomplicated SAB - AP-SA02 | Experimental | Anti-staphylococcal bacteriophage Receives: Biological: AP-SA02 |
| Phase 1b Uncomplicated SAB - Placebo | Placebo comparator | Inactive Isotonic Saline Solution Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days post completion of best available antibiotic therapy, up to 81 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start26 Apr 2022
- Primary completion7 Nov 2024
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armata Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Deborah Birx, MD, Study director, Armata Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184764
- Sponsor's protocol ID
- AP-SA02-101
- Acronym
- diSArm
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2021
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05184764
- Acronym / sponsor ID
- diSArm / AP-SA02-101
- Conditions
- Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia, Bacteremia Staph, Bacteremia Due to Staphylococcus Aureus
- Keywords
- Bacteriophage, Phage, Bacteremia, Staphylococcus Aureus, Staphylococcus, SAB
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Armata Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Phase 2a Complicated SAB - AP-SA02 | Experimental | Biological: AP-SA02Anti-staphylococcal bacteriophage |
| Phase 2a Complicated SAB- Placebo | Placebo comparator | Other: PlaceboInactive Isotonic Saline Solution |
| Phase 1b Uncomplicated SAB - AP-SA02 | Experimental | Biological: AP-SA02Anti-staphylococcal bacteriophage |
| Phase 1b Uncomplicated SAB - Placebo | Placebo comparator | Other: PlaceboInactive Isotonic Saline Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP-SA02Bacteriophage administered via intravenous bolus infusion | Biological | Phase 1b Uncomplicated SAB - AP-SA02, Phase 2a Complicated SAB - AP-SA02 |
| PlaceboInactive Placebo administered via intravenous bolus infusion | Other | Phase 1b Uncomplicated SAB - Placebo, Phase 2a Complicated SAB- Placebo |
Primary outcome
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.
5 secondary outcomes
Clinical Improvement or Response at Day 12
Time frame: 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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Armata Pharmaceuticals, Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Birx, MD study director
Armata Pharmaceuticals, Inc.
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AP-SA02 in people with Bacteremia and Staphylococcus Aureus, run by Armata Pharmaceuticals, Inc. at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.