Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Safety, Tolerability, and Efficacy of Intravenous AP-SA02 as an Adjunct to Best Available Antibiotic Therapy for the Treatment of Adults With Bacteremia Due to Staphylococcus Aureus (diSArm)
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- STATUS
- Recruiting
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- End date
- Dec 28, 2023
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- participants needed
- 50
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- sponsor
- Armata Pharmaceuticals, Inc.
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
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
| Condition | Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia, Bacteremia Staph, Bacteremia Due to Staphylococcus Aureus |
|---|---|
| Treatment | Placebo, AP-SA02 |
| Clinical Study Identifier | NCT05184764 |
| Sponsor | Armata Pharmaceuticals, Inc. |
| Last Modified on | 28 October 2022 |
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