EUCTR2019-003282-17-DK进行中（未招募）1 期
Short course antibiotic treatment of Gram-negative bacteremia: A multicenter, randomized, non-blinded, non-inferiority interventional study - GNB5
Thomas Benfield0 个研究点目标入组 380 人开始时间: 2019年12月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
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
- •Age >18 years
- •Blood culture positive for Gram-negative bacteria
- •Evidence of urinary tract source of infection (positive urine culture or at least one clinical symptom compatible with urinary tract infection)
- •Antibiotic treatment with antimicrobial activity to Gram-negative bacteria administrated within 12 hours of first blood culture
- •Temperature =<37,8°C at randomization
- •Clinically stabile (SBP = 90 mm Hg, HR = 100/min., RR = 24/min., SAT = 90%) at randomization
- •Oral and written informed consent
- •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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 190
排除标准
- •Antibiotic treatment (>2 day) with antimicrobial activity to Gram-negative bacteria within 14 days
- •Gram-negative bacteremia within 30 days of blood culture
- •Immunosuppression (Untreated HIV-infection, neutropenia (absolute neutrophil count < 1.0 x 109/l, untreated terminal cancer, corticosteroid treatment (>= 20 mg/day prednisone or the equivalent for >14 days) within the last 30 days, chemotherapy within the last 30 days, immunosuppressive agents (ATC-code L04A), immunosuppressed after solid organ transplantation, asplenia)
- •Polymicrobial growth in blood culture
- •Bacteremia with non-fermenting Gram-negative bacteria (Acinetobacter spp, Burkholderia spp, Pseudomonas spp), Brucella spp, or Fusobacterium spp
- •Failure to remove source of infection within 72 hours of first blood culture (e.g. change of catheter a demure)
- •Pregnancy or breastfeeding
研究者
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