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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05184764
Recruitment Status : Recruiting
First Posted : January 11, 2022
Last Update Posted : May 24, 2023
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Armata Pharmaceuticals, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Bacteremia Staphylococcus Aureus Staphylococcus Aureus Bacteremia Bacteremia Staph Bacteremia Due to Staphylococcus Aureus Biological: AP-SA02 Other: Placebo Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 26, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: AP-SA02
Anti-staphylococcal bacteriophage
 Biological: AP-SA02
Bacteriophage administered via intravenous bolus infusion
Placebo Comparator: Placebo
Inactive isotonic solution
 Other: Placebo
Inactive Placebo administered via intravenous bolus infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05184764


Contacts
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Contact: Bryan Kadotani 310-665-2928 bkadotani@armatapharma.com
Contact: Pierre Kyme, PhD 310-665-2928 ext 234

Locations
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United States, California
University of California, San Diego (UCSD) - Medical Center Recruiting
La Jolla, California, United States, 92037
Contact: Elizabeth Lampley    619-543-3108    elampley@health.ucsd.edu   
Principal Investigator: Saima Aslam, MD         
University of California, Los Angeles (UCLA) - Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Yesenia Calzada       ycalzada@mednet.ucla.edu   
Principal Investigator: Paul Allyn, MD         
United States, Florida
University of Florida (UF) - Division of Infectious Disease Recruiting
Gainesville, Florida, United States, 32610
Contact: Rodrigo Alcala       rodrigo.alcala@medicine.ufl.edu   
Principal Investigator: Gary Wang, MD         
University of South Florida Recruiting
Tampa, Florida, United States, 33620
Contact: Avennette Pinto    813-974-5891    apinto3@usf.edu   
Principal Investigator: Kami Kim, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
Contact: Lauren Stelmash    410-550-1131    lstelma2@jhmi.edu   
Principal Investigator: Mamuka Machaidze, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Rupali Ranade       rranade@tuftsmedicalcenter.org   
Principal Investigator: Brian Chow, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48103
Contact: Muhammad Hussain    734-763-5219      
Principal Investigator: Jihoon Baang, MD         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Melissa Resk       mresk1@hfhs.org   
Contact: Katrina Williams    313-916-5401    KWILLI35@hfhs.org   
Principal Investigator: Mayur S Ramesh, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Bola Omotosho    718-920-6565    Jomotosh@montefiore.org   
Principal Investigator: Paul Riska, MD         
The Jamaica Hospital Medical Center Recruiting
Jamaica, New York, United States, 11418
Contact: Kelly Cervellione    646-872-8659    kcervell@jhmc.org   
Principal Investigator: Khalid Gafoor, MD         
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Hui Zhan    347-306-2156    hui.zhan@mssm.edu   
Principal Investigator: Deena Altman, MD         
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Elizabeth Zieser-Misenheimer    336-716-0275    ezieserm@wakehealth.edu   
Principal Investigator: John Sanders, MD, MPH         
United States, Oregon
Portland Veterans Affairs Medical Center Recruiting
Portland, Oregon, United States, 97239
Contact: Katelyn West    971-222-7914    katelyn.west@va.gov   
Principal Investigator: Christopher Pfeiffer, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Fadi Shehadeh    401-444-4969    fanti.sechante@lifespan.org   
Principal Investigator: Eleftherios Mylonakis, MD         
United States, Wisconsin
Froedtert Hospital and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Sonija Parker       smparker@mcw.edu   
Principal Investigator: Jane Wainaina, MD         
Sponsors and Collaborators
Armata Pharmaceuticals, Inc.
United States Department of Defense
Investigators
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Study Director: Mina Pastagia, MD, MS Armata Pharmaceuticals, Inc.
More Information
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Additional Information:

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Responsible Party: Armata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05184764    
Other Study ID Numbers: AP-SA02-101
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Armata Pharmaceuticals, Inc.:
Bacteriophage
Phage
Bacteremia
 Staphylococcus Aureus
Staphylococcus
SAB
Additional relevant MeSH terms:
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Staphylococcal Infections
Bacteremia
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes