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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353951
• Other study ID #: GRACE-01
• Status: Completed
• Phase: N/A
• First received: July 18, 2006
• Last updated: May 19, 2008
• Start date: September 2006
• Est. completion date: July 2007

Study information

• Verified date: May 2008
• Source: Cardiff University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3402
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years and over.

• With acute or worsened cough with a duration of up to and including 28 days, or a clinical presentation that suggests a lower respiratory tract infection.

• Consulting for the first time within this illness episode.

• Seen within normal consulting hours.

• Able to fill out study materials.

• Who have provided written, informed consent to participate.

Exclusion Criteria:

• Previous study participants.

• Immunocompromised.

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

Locations

Country	Name	City	State
United Kingdom	GRACE Network in Cardiff	Cardiff

Sponsors (5)

Lead Sponsor	Collaborator
Cardiff University	European Commission, Universiteit Antwerpen, University of Southampton, Utrecht University

Country where clinical trial is conducted

United Kingdom, 

External Links

•   GRACE website