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
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Bacteremia
- 发起方
- Armata Pharmaceuticals, Inc.
- 入组人数
- 56
- 试验地点
- 51
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02.
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
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
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02.
时间窗: Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81).
Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0. Per SAP, all patients with uncomplicated SAB (Phase 1 Cohort 1 and Cohort 2) will be combined.
次要结局
- Clinical Improvement or Response at Day 12(12 Days)
- Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy as Assessed by the Investigator(7 days post completion of best available antibiotic therapy, up to 60 days.)
- Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy Assessed by the CEAC(7 days post completion of best available antibiotic therapy, up to 60 days.)
- Clinical Improvement or Response as Assessed by the Investigator at 28 Days Post Completion of Best Available Antibiotic Therapy(28 days post completion of best available antibiotic therapy, up to 81 days.)
- Clinical Improvement or Response as Assessed by the CEAC at 28 Days Post Completion of Best Available Antibiotic Therapy(28 days post completion of best available antibiotic therapy, up to 81 days.)