GRACE - Genómica para combatir la resistencia a los antibióticos en las infecciones respiratorias de vía baja adquiridas en la comunidad en Europa (Genomics to combat resistance against antibiotics in community-acquired LTRI in Europe). Workpackage 10. Antibiotic Trial One. - GRACE AT ONE

• Conditions: Infección respiratoria de vía baja (Lower respiratory tract infection)

• Registration Number: EUCTR2007-001586-15-ES
• Lead Sponsor: niversity of Southampton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-07
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

• Aged 18 years to 60 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 will be included)
• 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)
* Patients who are pregnant
* Patients who are allergic to penicillin
* Patients with history/physical examination suggestive of community acquired pneumonia (CAP) (16) - i.e. new focal chest signs (focal crepitations or bronchial breathing) plus systemic features (high fever, vomiting, severe diarrhoea).

Study & Design

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