Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
NCT ID: NCT05184764
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2022-04-26
2025-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AP-SA02
Anti-staphylococcal bacteriophage
AP-SA02
Bacteriophage administered via intravenous bolus infusion
Placebo
Inactive isotonic solution
Placebo
Inactive Placebo administered via intravenous bolus infusion
Interventions
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AP-SA02
Bacteriophage administered via intravenous bolus infusion
Placebo
Inactive Placebo administered via intravenous bolus infusion
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Left-sided infectious endocarditis by modified Duke criteria
* Known or suspected brain abscess or meningitis
* Known allergy to phage products
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Armata Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Deborah Birx, MD
Role: STUDY_DIRECTOR
Armata Pharmaceuticals, Inc.
Locations
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Banner University Medical Center
Tucson, Arizona, United States
University of California, San Diego (UCSD) - Medical Center
La Jolla, California, United States
University of Southern California Keck School of Medicine
Los Angeles, California, United States
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
University of Florida (UF) - Division of Infectious Disease
Gainesville, Florida, United States
University of Florida - Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
The Jamaica Hospital Medical Center
Jamaica, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina - Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Regional One Healthcare
Memphis, Tennessee, United States
Methodist Hospital Research Institute - Houston
Houston, Texas, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 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
Countries
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Related Links
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Armata Pharmaceuticals, Inc.
Other Identifiers
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AP-SA02-101
Identifier Type: -
Identifier Source: org_study_id
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