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

March 29, 2024 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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

50

Phase

  • 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 Backup

Study Locations

  • Australia
      • Adelaide, Australia
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Morgyn Warner, MD
      • Clayton, Australia
      • Melbourne, Australia
      • Melbourne, Australia
        • Recruiting
        • The Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Anton Peleg, MD
      • Westmead, Australia
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center
        • Contact:
        • Principal Investigator:
          • Donald Perry, MD
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California, San Diego (UCSD) - Medical Center
        • Principal Investigator:
          • Saima Aslam, MD
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles (UCLA) - Medical Center
        • Contact:
        • Principal Investigator:
          • Paul Allyn, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California Keck School of Medicine
        • Contact:
        • Principal Investigator:
          • Saahir Khan, MD, PhD
      • Torrance, California, United States, 90502
        • Recruiting
        • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Loren Miller, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Rocky Mountain Regional VA Medical Center
        • Contact:
        • Principal Investigator:
          • Lindsay Nicholson, MD
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida (UF) - Division of Infectious Disease
        • Contact:
        • Principal Investigator:
          • Gary Wang, MD
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida - Jacksonville
        • Principal Investigator:
          • Mehdi Mirsaeidi, MD
        • Contact:
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Kami Kim, MD
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
        • Principal Investigator:
          • Colleen Kraft, MD
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Mamuka Machaidze, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Recruiting
        • University of Michigan
        • Contact:
          • Muhammad Hussain
          • Phone Number: 734-763-5219
        • Principal Investigator:
          • Jihoon Baang, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mayur S Ramesh, MD
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Paul Riska, MD
      • Jamaica, New York, United States, 11418
        • Recruiting
        • The Jamaica Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Khalid Gafoor, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • Deena Altman, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina - Chapel Hill School of Medicine
        • Contact:
        • Principal Investigator:
          • Anne Friedland, MD
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • John Sanders, MD, MPH
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Principal Investigator:
          • Ralph Rogers, MD
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38103
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Methodist Hospital Research Institute - Houston
        • Principal Investigator:
          • Eleftherios Mylonakis, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital and the Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Jane Wainaina, MD

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

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
Intervention / Treatment
Placebo Comparator: Placebo
Inactive isotonic solution
Other: Placebo
Inactive Placebo administered via intravenous bolus infusion
Experimental: AP-SA02
Anti-staphylococcal bacteriophage
Biological: AP-SA02
Bacteriophage administered via intravenous bolus infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) of multiple doses of intravenous AP-SA02
Time Frame: Day 1 first dose through Day 12 or through End of Study for serious AEs
Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0
Day 1 first dose through Day 12 or through End of Study for serious AEs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Improvement or Response at Day 12
Time Frame: Day 12
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) 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
Day 12
Clinical Improvement or Response at 7 days after completion of antibiotic therapy
Time Frame: 7 days post completion of best available antibiotic therapy
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) 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
Clinical Improvement or Response at End of Study
Time Frame: 28 days post completion of best available antibiotic therapy
Description of clinical outcome in the Microbiological Intent-to-Treat (mITT) 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

Collaborators and Investigators

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

Sponsor

Armata Pharmaceuticals, Inc.

Collaborators

United States Department of Defense

Investigators

  • Study Director: Mina Pastagia, MD, MS, 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)

April 26, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 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)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

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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