An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care

Cough Clinical Trial

Official title: Genomics to Combat Resistance Against Antibiotics in Community-Acquired LRTI in Europe: GRACE. Workpackage 8. An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care

Status Completed

Clinical Trial Summary

The overall objective of GRACE is to combat the resistance of drugs that kill bacteria and other germs (antimicrobial) through integrating centres of research excellence and using the study of the entire DNA in a cell (genomics) to most appropriately investigate and manage community-acquired LRTI.

Grace-01 is the first study to be undertaken as part of GRACE and the aims of this study are to describe the presentation, diagnosis, investigation, management and outcomes for people with cough / chest infection in general medical practice in 13 primary care networks in 12 countries in Europe.

Clinical Trial Description

GRACE is a Network of Excellence focusing on the complex and controversial field of community-acquired lower respiratory tract infections (LRTI), which is one of the leading reasons for seeking medical care. It is funded through Funding Program 6 of the European Union. The prescription of antibiotics for LRTI accounts for a major proportion of antibiotics used in the community, and contributes to the rising prevalence of resistance among major human pathogens. The overall objective of GRACE is to combat antimicrobial resistance through integrating centres of research excellence and exploiting genomics in the investigation and management of community-acquired LRTI

The first study undertaken as part of GRACE is GRACE-01, an observational study, which aims to describe the presentation, management (evaluation and treatment decisions) and outcomes for people with cough / chest infection in general medical practice in 13 primary care networks in Europe. This will be an observational study of current practice involving no experimental procedures or interventions.

Other objectives Of GRACE-01 are:

1. To describe variation in management of cough / chest infection including antibiotic prescribing in primary care between, and within, selected European countries in order to explain how good practice could be made explicit and generalised.

2. To identify priorities for intervention studies aimed at enhancing antibiotic prescribing for community acquired cough / chest infection and other aspects of management.

3. To contribute to developing interventions aimed at enhancing antibiotic prescribing and other aspects of management of community-acquired cough / chest infection that are applicable across the European Union (EU), and also to interventions that are relevant to unique local situations within Europe.

There will be two recruitment periods, one beginning on the second of October 2006 or soon thereafter and a second beginning on the first of February 2007 or soon thereafter. The goal is for each of the 13 participating European networks to recruit a total of 150 patients during each of these recruitment periods. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chest Infection
• Communicable Diseases
• Cough
• Infection
• Lower Respiratory Tract Infection (LRTI)
• Respiratory Tract Infections

• NCT number: NCT00353951
• Study type: Observational
• Source: Cardiff University
• Status: Completed
• Phase: N/A
• Start date: September 2006
• Completion date: July 2007