Clinical trial NCT05184764: Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bacteremia
Staphylococcus Aureus
Staphylococcus Aureus Bacteremia
Bacteremia Staph
Bacteremia Due to Staphylococcus Aureus
Keywords: Bacteriophage
Phage
Bacteremia
Staphylococcus Aureus
Staphylococcus
SAB
Lead sponsor: Armata Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2022-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) of multiple doses of intravenous AP-SA02
timeFrame: Day 1 first dose through Day 12 or through End of Study for serious AEs
Secondary outcomes:
measure: Clinical Improvement or Response at Day 12
timeFrame: Day 12
measure: Clinical Improvement or Response at 7 days after completion of antibiotic therapy
timeFrame: 7 days post completion of best available antibiotic therapy
measure: Clinical Improvement or Response at End of Study
timeFrame: 28 days post completion of best available antibiotic therapy
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego (UCSD) - Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California Keck School of Medicine
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA) - Medical Center
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
city: Gainesville
country: United States
facility: University of Florida (UF) - Division of Infectious Disease
state: Florida
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Jamaica
country: United States
facility: The Jamaica Hospital Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill School of Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: Regional One Healthcare
state: Tennessee
city: Houston
country: United States
facility: Methodist Hospital Research Institute - Houston
state: Texas
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Clayton
country: Australia
facility: Monash Health
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
Study officials:
affiliation: Armata Pharmaceuticals, Inc.
name: Deborah Birx, MD
role: STUDY_DIRECTOR
References: