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AP-SA02 for Staphylococcal Bacteremia (diSArm Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Armata Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized female or male ≥ 18 years old

Be older than 18 years old

Must not have

Known or suspected brain abscess or meningitis

Left-sided infectious endocarditis by modified Duke criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 first dose through day 12 or through end of study for serious aes

Summary

This trial is testing a new drug to see if it is safe and effective in treating adults with bacteremia (a bacterial infection in the blood) due to Staphylococcus aureus.

Who is the study for?

Adults over 18 with a Staphylococcus aureus (SA) blood infection who are hospitalized can join. They must have their source of SA infection under control or a plan for it, not be pregnant or breastfeeding, and agree to use contraception if they can have children. Those with certain heart infections, brain abscesses, meningitis, allergies to phage products, or other bacterial growth besides SA cannot participate.

What is being tested?

This study is testing the safety and effectiveness of AP-SA02 given through an IV as an extra treatment alongside the best available antibiotic therapy versus just the antibiotics alone in treating adults with SA bacteremia. It's randomized and double-blind meaning neither participants nor researchers know who gets what treatment until after results are collected.

What are the potential side effects?

Potential side effects of AP-SA02 aren't detailed here but could include reactions related to infusion such as discomfort at injection site or allergic responses since it's a new treatment being evaluated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older and currently hospitalized.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or might have a brain infection.

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I have an infection in the left side of my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 first dose through day 12 or through end of study for serious aes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 first dose through day 12 or through end of study for serious aes

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 first dose through day 12 or through end of study for serious aes for reporting.