CompletedPhase 1/2

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

United States56 participantsStarted 2022-04-26

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02.

Timeframe: Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81).

Trial details

NCT IDNCT05184764

SponsorArmata Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-07

Results submitted2025-11-10

View on ClinicalTrials.gov More Bacteremia trials