Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
- Conditions
- BacteremiaBacteremia StaphStaphylococcus AureusBacteremia Due to Staphylococcus AureusStaphylococcus Aureus Bacteremia
- Interventions
- Biological: AP-SA02Other: Placebo
- Registration Number
- NCT05184764
- Lead Sponsor
- Armata Pharmaceuticals, Inc.
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AP-SA02 AP-SA02 Anti-staphylococcal bacteriophage Placebo Placebo Inactive isotonic solution
- Primary Outcome Measures
Name Time Method Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) of multiple doses of intravenous AP-SA02 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
Name Time Method Clinical Improvement or Response at Day 12 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
Clinical Improvement or Response at End of Study 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
Clinical Improvement or Response at 7 days after completion of antibiotic therapy 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
Trial Locations
- Locations (28)
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
Montefiore Medical Center
🇺🇸Bronx, New York, 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
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