A Phase 3, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of ABSSSI: REVIVE-1
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 17
- 主要终点
- ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.
研究概览
简要总结
This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.
详细描述
This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin. Patients will receive either iclaprim or vancomycin for 5 to 14 days. Patients will be evaluated daily up to early time point (ETP), then every 48 to 72 hours through the end of treatment. Patients will also be evaluated at the test of cure (TOC) visit (7 to 14 days post-EOT), and will have a Late Follow-Up (LFU) visit (28 to 32 days post-first dose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent;
- •≥18 years of age;
- •a bacterial infection of the skin with a lesion size area of at least 75 cm2;
- •a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
- •the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).
排除标准
- •severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
- •infected diabetic foot ulcers;
- •infected decubitus ulcers;
- •necrotizing fasciitis or gangrene;
- •uncomplicated skin or skin structure infection;
- •infections associated with a prosthetic device;
- •suspected or confirmed osteomyelitis;
- •conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.
研究组 & 干预措施
iclaprim
iclaprim 80 mg intravenous every 12 hours
干预措施: iclaprim (Drug)
vancomycin
vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
干预措施: vancomycin (Drug)
结局指标
主要结局
≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.
时间窗: Baseline and 48-72 hours after first dose of study drug
≥20% reduction in lesion size at 48 to 72 hours (Early Time Point \[ETP\]) compared to baseline in all randomized patients (ITT).
次要结局
- Resolution or Near Resolution of Lesion at Test of Cure Visit(7 to14 days after the end of treatment)