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

Purpose

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

Conditions

Bacteremia
Staphylococcus Aureus
Staphylococcus Aureus Bacteremia
Bacteremia Staph
Bacteremia Due to Staphylococcus Aureus

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

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

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental AP-SA02	Anti-staphylococcal bacteriophage	Biological: AP-SA02 Bacteriophage administered via intravenous bolus infusion
Placebo Comparator Placebo	Inactive isotonic solution	Other: Placebo Inactive Placebo administered via intravenous bolus infusion

Recruiting Locations

More Details

NCT ID: NCT05184764
Status: Completed
Sponsor: Armata Pharmaceuticals, Inc.

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.