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临床试验/EUCTR2007-001586-15-SK
EUCTR2007-001586-15-SK进行中(未招募)1 期

GRACE (Genomics to combat resistance against antibiotics in community acquired lower respiratory tract infections in Europe) WP10: Antibiotic Trial One - GRACE, wp10

niversity of Southampton0 个研究点目标入组 3,000 人开始时间: 2009年12月4日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
3,000

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 to 59 years and 60 years and over (enrolment will be done in such a way with the aim to include 1500 patients under 60 and 1500 patients of 60 years and older)
  • Consultation with acute cough as the main symptom (up to and including 28 days duration) or those in whom the general practitioner suspects the presence of acute lower respiratory tract infection
  • Immuno-competent subject (no serious immunological deficiencies)
  • Consultation for the first time within this illness episode
  • Ability to fill out study materials
  • Subject provided written, informed consent to participate
  • Subject has not been included earlier in the current GRACE trial, either as a case or a patient
  • 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

  • Patients who have had antibiotics in the previous month
  • Patients who are unable to properly consent or fill out the diary (dementia, psychosis, severe depression)
  • Patients who are pregnant
  • Allergy to penicillin or contra-indication for amoxicillin because of a major interaction with other medication
  • community acquired pneumonia in history or found during physical examination i.e. new focal chest signs (focal crepitations or bronchial breathing) plus systemic features (high fever, vomiting, severe diarrhoea) - clinically diagnosed CAP on ethical grounds (practitioners would be very unlikely to be willing to randomise patients with CAP).

研究者

发起方
niversity of Southampton

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NL-OMON33677niversity of Southampton, contact person Martina Dorward300