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NCT05184764 Clinical Trial

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

Bacteremia Clinical Trial

— diSArm  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05184764
Other study ID # AP-SA02-101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 26, 2022
Est. completion date March 2025

Study information
Verified date March 2024
Source Armata Pharmaceuticals, Inc.
Contact Thomas Feinberg
Phone 781-820-2787
Email tfeinberg@armatapharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 Staphylococcus aureus

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 information / eligibility
Status Recruiting
Enrollment 50
Est. completion date March 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• AP-SA02
Bacteriophage administered via intravenous bolus infusion
Other:
• Placebo
Inactive Placebo administered via intravenous bolus infusion

Locations
Country Name City State
Australia Royal Adelaide Hospital Adelaide
Australia Monash Health Clayton
Australia Royal Melbourne Hospital Melbourne
Australia The Alfred Hospital Melbourne
Australia Westmead Hospital Westmead
United States University of Michigan Ann Arbor Michigan
United States Emory University Hospital Midtown Atlanta Georgia
United States Rocky Mountain Regional VA Medical Center Aurora Colorado
United States Johns Hopkins University Baltimore Maryland
United States Tufts Medical Center Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States University of North Carolina - Chapel Hill School of Medicine Chapel Hill North Carolina
United States Henry Ford Health System Detroit Michigan
United States University of Florida (UF) - Division of Infectious Disease Gainesville Florida
United States Methodist Hospital Research Institute - Houston Houston Texas
United States University of Florida - Jacksonville Jacksonville Florida
United States The Jamaica Hospital Medical Center Jamaica New York
United States University of California, San Diego (UCSD) - Medical Center La Jolla California
United States University of California, Los Angeles (UCLA) - Medical Center Los Angeles California
United States University of Southern California Keck School of Medicine Los Angeles California
United States Regional One Healthcare Memphis Tennessee
United States Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin
United States Icahn School of Medicine at Mount Sinai New York New York
United States Rhode Island Hospital Providence Rhode Island
United States University of South Florida Tampa Florida
United States Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center Torrance California
United States Banner University Medical Center Tucson Arizona
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Armata Pharmaceuticals, Inc. United States Department of Defense

Countries where clinical trial is conducted

United States,  Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) of multiple doses of intravenous AP-SA02 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 Clinical Improvement or Response at 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
Secondary Clinical Improvement or Response at 7 days after completion of 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
Secondary Clinical Improvement or Response at End of Study 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
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