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

Phase 1

Conditions: ower respiratory tract infection
MedDRA version: 9.1Level: LLTClassification code 10008477Term: Chest infection
MedDRA version: 9.1Level: LLTClassification code 10024968Term: Lower respiratory tract infection

Registration Number: EUCTR2007-001586-15-SK

Lead Sponsor: niversity of Southampton

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3000

Inclusion Criteria

• 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

Exclusion Criteria

• 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).