EUCTR2006-004886-33-GR进行中（未招募）不适用
A DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL OF THE SAFETY AND IMMUNOMODULATORY THERAPY FOR THE MANAGEMENT OF SEPSIS
niversity of Athens, Medical school0 个研究点开始时间: 2007年1月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •One or more of the following infections: a) primary or secondary bacteremia by Gram-negative bacteria, b) acute pyelonephritis, or c) intrabdominal infection. Only one episode of infection per patient will be enrolled. Both patients with community-acquired and nosocomial infections are eligible for the study. The presence of at least two of the following criteria of sepsis according to ACCP/SCCM (8) a) body temperature >380C or <360C; b) pulse rate >90/min; c) breath rate >20/min or Pco2<32mmHg; and/or d) leukocytosis (white blood cell count >12,000/µl) or leukopenia (white blood cell count <4,000/µl) or >10% band forms
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of HIV infection
- •Intake of corticosteroids at a dose more than or equal to 1mg/kg of equivalent prednisone for more than one month
- •Neutropenia as <500 neutrophils/µl
- •Selection by the attending physician of a macrolide as empiric antimicrobial therapy for the infection making the patient ineeligible for the study
研究者
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