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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 人开始时间: 2019年3月14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
336

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

  • 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
  • F.1.3.1 Number of subjects for this age range 168

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

研究者

发起方
Thomas Benfield

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