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临床试验/EUCTR2019-000404-15-DK
EUCTR2019-000404-15-DK
进行中(未招募)
1 期

Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial - CAP5

Thomas Benfield0 个研究点目标入组 336 人2019年3月14日

概览

阶段
1 期
干预措施
未指定
疾病 / 适应症
Community-acquired pneumonia
发起方
Thomas Benfield
入组人数
336
状态
进行中(未招募)
最后更新
去年

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2019年3月14日
结束日期
待定
最后更新
去年
研究类型
Interventional clinical trial of medicinal product
性别
All

研究者

发起方
Thomas Benfield

入排标准

入选标准

  • o Hospitalized with community\-acquired pneumonia; defined as new pulmonary infiltrate on chest X\-ray and at least one symptom compatible with pneumonia (cough, fever, dyspnoea and/or chest pain)
  • o Initiation of antibiotics within 12 hours of the time of the chest X\-ray with an infiltrate
  • o Age \= 18 years
  • o Afebrile (temp \= 37,8°C) for 48 hours at randomization
  • o Clinically stable at randomization (SBP \= 90 mm Hg, HR \= 100/min., RR \= 24/min., SAT \= 90%)
  • 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 168
  • F.1\.3 Elderly (\>\=65 years) yes

排除标准

  • a) Immunosuppression (HIV\-positive, neutropenia (\<1 x 10^9/L), corticosteroid treatment (\= 10 mg/d of prednisone or the equivalent for \>30 days), chemotherapy within the past 90 days, untreated terminal cancer, immunosuppressive agents, immunosuppressed after solid organ transplantation, asplenia)
  • b) Hospitalization during the previous 14 days
  • c) Antibiotic treatment (\>2 days) within the past 30 days, directed at lower respiratory tract pathogens
  • d) Uncommon cause requiring longer duration of antimicrobial therapy (Pseudomonas aeruginosa, Staphylococcus aureus, Mycobacterium spp., fungi)
  • e) Extrapulmonary infection (e.g. endocarditis, meningitis, or abscess)
  • f) Pleural empyema or lung abscess
  • g) Pleural effusion requiring drainage tube
  • h) Intensive care unit (ICU) admittance
  • i) Pregnancy and breastfeeding

结局指标

主要结局

未指定

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