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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 first dose through day 12 or through end of study for serious aes
Awards & highlights

diSArm Trial 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.Check my eligibility
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.See study design
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.

diSArm Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years or older and currently hospitalized.

diSArm Trial Timeline

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acetaminophen
Secondary outcome measures
Clinical Improvement or Response at 7 days after completion of antibiotic therapy
Clinical Improvement or Response at Day 12
Clinical Improvement or Response at End of Study

diSArm Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AP-SA02Experimental Treatment1 Intervention
Anti-staphylococcal bacteriophage
Group II: PlaceboPlacebo Group1 Intervention
Inactive isotonic solution

Find a Location

Who is running the clinical trial?

Armata Pharmaceuticals, Inc.Lead Sponsor
12 Previous Clinical Trials
495 Total Patients Enrolled
United States Department of DefenseFED
863 Previous Clinical Trials
227,582 Total Patients Enrolled
Mina Pastagia, MD, MSStudy DirectorArmata Pharmaceuticals, Inc.
2 Previous Clinical Trials
287 Total Patients Enrolled

Media Library

AP-SA02 Clinical Trial Eligibility Overview. Trial Name: NCT05184764 — Phase 1 & 2
AP-SA02 2023 Treatment Timeline for Medical Study. Trial Name: NCT05184764 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can join this clinical trial at most?

"In order for this study to be completed, 50 eligible patients must be recruited. The sponsor, Armata Pharmaceuticals Inc., will oversee the trial from various locations; two of these being University of South Florida in Tampa and Montefiore Medical Center situated in Bronx, New york."

Answered by AI

Are new patients being accepted into this research project at the moment?

"This trial, which was originally posted on 4/26/2022 and has since been updated on 11/10/2022, is currently looking for participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
2022. "Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05184764.
~11 spots leftby Dec 2024
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