GRACE (Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe). Workpackage 10: Antibiotic trial one. - GRACE AT ONE
- Conditions
- ower Respiratory Tract InfectionMedDRA version: 9.1Level: LLTClassification code 10008477Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2007-001586-15-SE
- Lead Sponsor
- niversity of Southampton
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3000
Eligible patients will be:
- Aged 18 to 59 and 60 years and over (enrolment will be done in such way that 1500 patients under 60 and 1500 patients of 60 years and older)
- Consulting with acute cough as the main symptom (up to 28 days duration) or those in whom the general practitionor suspects the presence of acute LRTI
- Immunocompetent
-Consulting for the first time within this illness episode
-Able to fill out study material
- Who have provided written informed consent to participate
-Who have not been included earlier in the current GRACE trial, either as a case or control
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
Patients who have had antibiotics in the previous month, patients who are unable to properly consent or fill out the diary (dementia, psychosis, depression), patients who are pregnant, patients who are allergic to penicillin, and those with history/physical examination suggestive of community-acquired pneumonia - on ethical grounds, GPs would be very unlikely to be willing to randomise patients with pneumonia.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method