NCT00462878已完成不适用
MERONEM: Observational Study About Efficacy of Meropenem in Comparison of Meropenem and Glycopeptide in Treatment of Neutropenia Febrile in Allogenic Blood Stem Cell Transplantation Patients
PETHEMA Foundation64 个研究点 分布在 1 个国家目标入组 392 人开始时间: 2002年11月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 392
- 试验地点
- 64
研究概览
简要总结
Observational study to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.
详细描述
Observational study cost-effectivity to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.
The study will be done in two consecutive cohorts of patients. First cohort: meropenem 1g/8h ev Second cohort: meropenem 1g/8h and glycopeptide (vancomycin 1g/12 h or teicoplanin 400 mg/24h)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age > 18 years
- •Patients submitted to allogenic transplant
- •Neutropenia: neutrophils account < 500/mm3 or neutrophils account < 1000/mm3 with prevision to decrease until 500/mm3 at the next 24-48 h
- •Signs and symptoms to infection
- •Fever: Temperature> 38,3 ºC registered one time, or 38 ºC en two times separated 60 minutes in a period of 12 h.
排除标准
- •Medical history of meropenem or glycopeptides hypersensitivity
- •Renal failure or creatinine in serum > 2,25 mg/dl or creatinine clearance < 40 ml
- •Liver insufficiency
- •Childbearing potential or breast feeding period
- •Contraindications to meropenem, vancomycin or teicoplanin
研究者
研究点 (64)
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