跳至主要内容
临床试验/EUCTR2007-001586-15-DE
EUCTR2007-001586-15-DE进行中(未招募)1 期

GRACE (Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe).Workpackage 10: Antibiotic Trial One - GRACE AT ONE

niversity of Southampton0 个研究点目标入组 3,000 人开始时间: 2007年12月11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

  • Eligible patients will be those who are:
  • Aged 18 years to 59 years and 60 years and over (enrolment will be done in such a way that 1500 patients under 60 and 1500 patients of 60 years and older)
  • Consulting 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 (no serious immunological deficiencies)
  • Consulting for the first time within this illness episode
  • Able to fill out study materials
  • Who have provided written, informed consent to participate
  • Who have not been included earlier in the current GRACE trial, either as a case or a control 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 (altered flora): patients who are unable to properly consent or fill out the diary (dementia, psychosis, severe depression): and patients who are pregnant; patients who are allergic to penicillin or have a contraindication for Amoxicillin because of a major interaction with other medication, and those with history/physical examination suggestive of community acquired pneumonia - on ethical grounds; practitioners would be very unlikely to be willing to randomise patients with CAP.
  • Patients with a highly limited renal function (GFR <30ml/min) will be excluded.

研究者

发起方
niversity of Southampton

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