NCT00035854已完成3 期
Linezolid IV/PO for the Treatment of Vancomycin-Resistant Enterococcus Infections in Children
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 13
- 试验地点
- 22
- 主要终点
- Investigator's and sponsor's evaluation of patient clinical outcome.
研究概览
简要总结
This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized/chronic care pediatric patients (birth through 17 years)
- •Known infections due to vancomycin-resistant enterococcus species, including diagnosis of hospital-acquired pneumonia, complicated skin and skin structure infections, catheter-related bacteremia, bacteremia of unidentified source, and other infections
- •Requires a minimum of 3 days of IV medication
- •Patients with mixed infections due to VRE & gram negative bacteria are allowed to enroll in the study. For most of the infections, 2 or more of additional symptoms are required.
排除标准
- •Potentially effective concomitant antibiotic
- •A high surgical cure rate
- •Medical conditions which would preclude clinical evaluation or require treatment of longer duration than 28 days
- •24 hours of antibiotic treatment within 48 hours of study entry (unless pre-approved)
- •Having an infected device that could not be removed
结局指标
主要结局
Investigator's and sponsor's evaluation of patient clinical outcome.
次要结局
- Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
研究者
研究点 (22)
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