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

a study on Bacteremia Staphylococcus Aureus Staphylococcus Aureus Bacteremia Bacteremia Staph Bacteremia Due to Staphylococcus Aureus

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Paul Allyn, MDLoren Miller, MD

Description

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

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

Details

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.

Keywords

Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia, Bacteremia Staph, Bacteremia Due to Staphylococcus Aureus, Bacteriophage, Phage, Staphylococcus, SAB, Staphylococcal Infections

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles (UCLA) - Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • University of Southern California Keck School of Medicine accepting new patients
    Los Angeles California 90033 United States

Lead Scientists at UCLA

  • Paul Allyn, MD
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 9 research publications
  • Loren Miller, MD
    HS Clinical Professor, Medicine. Authored (or co-authored) 159 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Armata Pharmaceuticals, Inc.
Links
Armata Pharmaceuticals, Inc.
ID
NCT05184764
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated