This study is to evaluate Safety & Tolerability of multiple doses of an experimental i.v. medication (called AP-SA02) in Phase 1b and to evaluate Efficacy, Safety & Tolerability of multiple doses of the same experimental medication in Phase 2a, as compared to Placebo in patients with certain bacterial infection (bacteria named Staphylococcus aureus) of your blood stream. The experimental drug or Placebo will be given in addition to any treatment given for the Blood stream infection by Staphylococcus aureus.
Armata Bacteriophage Study; disArm Study
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.
Bacterial infection, Staphylococcus aureus
All genders
18-100
Recruiting now
Overview
Principal Investigator: Brian Chow, MD
Contact Us
Rupali Ranade
Study details
Inclusion Criteria
- Blood culture result positive for Staphylococcus aureus bacteria within 48 to 72 hours of randomization in study.
- Have a plan for infection source control within 3 days after randomization or have source of infection already controlled.
- For 2a: at least one of the signs or symptoms for Blood stream infection among Temperature (>/=100.4 F), heart rate (>90 beats/minute); Respiratory rate (>20/minute); white blood cell count; Systolic blood pressure (>90 mm of Hg) or Pain at infection focus site.
Exclusion Criteria
- Growth of other bacteria in blood culture along with Staphylococcus aureus
- Received treatment with any potentially effective antibiotic for more than 48 hours for Phase 1b and more than 72 hours for Phase 2a.
- Left sided infectious endocarditis by modified Duke Criteria.
Study Requirements
- Study involvement/visit between 39 to 81 days with at least 5 inpatient days and 3 office/clinic visits.
- Total blood draw is about 9 times during 9 study-required visit points along with periodic EKGs.