A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects With Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population
研究概览
简要总结
The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).
详细描述
A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus.
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
- Double (Participant, Investigator)
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
- •Subjects are required to meet All of the following inclusion criteria:
- •Male or female, ≥ 18 years old
- •Presence of CABP requiring hospitalization
- •Presence of CABP meeting the following criteria:
- •I. confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection
- •MRSA Risk Factors
- •MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA
排除标准
- •Subjects must Not meet any of the following exclusion criteria at baseline:
- •History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
- •Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs
- •Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
- •More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization
- •End-stage renal disease [Creatinine Clearance (CrCl) < 15], including hemodialysis
- •Evidence of significant hepatic, hematological, or immunocompromising condition
研究组 & 干预措施
Ceftaroline
Ceftaroline fosamil 600 mg Intravenous (IV) administration over 60 minutes, every 8 hours (q8h); dosing to be adjusted for renal function; treatment duration 5 to 14 days
干预措施: Ceftaroline fosamil (Drug)
Ceftriaxone plus vancomycin
Ceftriaxone 2 g IV over 30 minutes once per day (q24h) plus vancomycin 15 mg/kg IV every 12 hours (q12h) initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
干预措施: Ceftriaxone plus vancomycin (Drug)
结局指标
主要结局
Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population
时间窗: Study Day 4
Clinical response was defined as meeting all of the following criteria: * Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline: * Cough * Dyspnea * Sputum production * Chest pain * Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007): * Temperature ≤ 37.8°C * Heart rate ≤ 100 beats/min * Respiratory rate ≤ 24 breaths/min * Systolic blood pressure ≥ 90 mmHg * Oxygen saturation ≥ 90% * Confusion/disorientation absent
Clinical Outcome at Test of Cure (TOC) in the MITT Population
时间窗: Test of Cure, an average of 3 weeks
An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were: Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required Failure: Subjects who meet either of the following criteria: * Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy * Death in which CABP is contributory Indeterminate: Study data are not available for evaluation of efficacy for any reason, including: * Death in which CABP is clearly noncontributory * Lost to follow-up * Extenuating circumstances precluding classification as a cure or failure A favorable clinical outcome at Test-of Cure (TOC) was clinical cure.
次要结局
未报告次要终点