A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 802
- 试验地点
- 1
- 主要终点
- Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
研究概览
简要总结
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.
详细描述
A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 years or older
- •Complicated skin and skin structure infection (cSSTI)
- •Infection of sufficient severity to warrant hospitalization
- •Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy
排除标准
- •Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug
- •Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens
- •Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease
- •Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb
- •Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock
研究组 & 干预措施
Ceftaroline fosamil
Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function.
干预措施: Ceftaroline fosamil (Drug)
Vancomycin plus aztreonam
Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function
干预措施: Vancomycin (Drug)
Vancomycin plus aztreonam
Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function
干预措施: Aztreonam (Drug)
结局指标
主要结局
Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
时间窗: 7 to 20 days after the last dose of study drug
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set
时间窗: 7 to 20 days after the last dose of study drug
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
次要结局
- Clinical Response at End of Treatment (EOT) in MITT Analysis Set(On day of last dose of study drug (or + 1 day))
- Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set(48 to 72 hours after first dose of study drug)
- Clinical Response at EOT in CE Analysis Set(On day of last dose of study drug (or +1 day))
- Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC(21 to 42 days after the last dose of study drug)
- Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME(7 to 20 days after the last dose of study drug)
- Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set(7 to 20 days after the last dose of study drug)
- Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set(7 to 20 days after the last dose of study drug)