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(352) 733-0111

diSArm

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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

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.

Details

Full study title 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
Protocol number OCR41653
ClinicalTrials.gov ID NCT05184764
Phase Phase 1/Phase 2

Eligibility

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

Lead researcher

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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