NCT01572831已完成3 期
A Pilot Study to Evaluate a Procalcitonin-Based Algorithm for Duration of Antibiotic Therapy in Critically Ill Patients
Fraser Health2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Antibiotic- free days and alive at 14 days after ICU admission
研究概览
简要总结
Patients in the ICU whose infection is resolving will be randomized to standard duration of antibiotics compared to duration determined by a combination of a procalcitonin value and a simple evaluation of clinical status.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (19 years and older) treated with ABx for reasons other than prophylaxis within the last 24 hours and who are admitted to a critical care environment.
排除标准
- •Declined consent
- •Any infection that according to evidence-based guidelines which would usually receive more than 2 weeks of antibiotic therapy including, but not limited to;
- •Infective endocarditis
- •Osteomyelitis
- •Undrained abscess
- •Not expected to survive 48 hours
- •Immunosuppression (HIV positive, any immunosuppressive medications, any steroid dose, neutrophil count less than 1.0)
- •Previously enrolled in this study
- •Presently enrolled in a separate study which is felt by study investigators to have biological or clinical process in conflict with this study.
结局指标
主要结局
Antibiotic- free days and alive at 14 days after ICU admission
时间窗: 14 days
次要结局
- mortality at 28 days(28 days)
- colonization/infection with VRE/MRSA over next 30 days(30 days)
- mortality at 90 days(90 days)
- ventilator days at 28 days(28 days)
- relapsed infection(30 days)
- rates of CDAD(30 days)
- ICU free days at 28 days(28 days)
- duration of abx in control arm for those with and without formal stewardship programs(14 days)
研究者
研究点 (2)
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