A Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of RX 3341 Compared With Tigecycline for the Treatment of Complicated Skin and Skin Structure Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.
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
- •Adult (≥18 years of age) men or women with cSSSI
- •Diagnosis of one of the following 3 types of cSSSI: wound infection that has developed within 30 days of surgery, trauma, or a bite injury; abscess that has developed in the 7 days before enrollment; or cellulitis that has developed in the 7 days before enrollment
- •Sexually active men and women of childbearing potential must agree to use an acceptable form of contraception, as determined by the investigator, during participation in the study and for 30 days after the final dose of study drug
- •The patient must be willing to comply with protocol requirements
排除标准
- •Medical history of hypersensitivity or allergic reaction to quinolones, tetracycline or tetracycline derivatives
- •Chronic or underlying skin condition at the site of infection
- •Infection involving prosthetic materials or foreign bodies (unless prosthetic material will be removed within 24 hours), infection associated with a human bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene or gas gangrene, burns covering ≥10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis
- •An infection that would normally have a high cure rate after surgical incision alone
- •Any infection expected to require other antimicrobial agents in addition to study drug
- •Receipt of >24 hours of systemic antibiotic therapy in the 7 days before enrollment
- •A severely compromised immune system
- •History of Child-Pugh Class B or C liver disease or severe renal impairment (creatinine clearance of <30 mL/minute)
- •Pregnancy or lactation
研究组 & 干预措施
1
干预措施: delafloxacin (Drug)
2
干预措施: delafloxacin (Drug)
3
干预措施: tigecycline (Drug)
结局指标
主要结局
Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
时间窗: 14-21 days after the last dose of study drug
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
次要结局
- Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)(14-21 days after the last dose of study drug)