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

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-DE
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-11
• Study Completion: 2011-04-05
• Last Update Posted: 14 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified