Status:
COMPLETED
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
Lead Sponsor:
Armata Pharmaceuticals, Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
Bacteremia
Staphylococcus Aureus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 Ant...
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 the...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05184764
Start Date
April 26 2022
End Date
January 14 2025
Last Update
October 3 2025
Active Locations (28)
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1
Banner University Medical Center
Tucson, Arizona, United States, 85719
2
University of California, San Diego (UCSD) - Medical Center
La Jolla, California, United States, 92037
3
University of Southern California Keck School of Medicine
Los Angeles, California, United States, 90033
4
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, United States, 90095